08.05.13
(a division of Johnson & Johnson)
$7.8 Billion
KEY EXECUTIVES:
Alex Gorsky, CEO & Chairman, JNJ
Dominic J. Caruso, VP, Finance & CFO, JNJ
Charles E. Austin, VP, Global Supply Chain, JNJ
Karen A. Licitra, Chairman, Global Medical Solutions Group, JNJ
Michel Orsinger, Worldwide Chairman, DePuy Synthes Companies
Gary Fischetti, Group Chairman, Orthopaedic Group, DePuy Synthes
Max Reinhardt, Worldwide President, DePuy Synthes Spine
Andrew Ekdahl, Worldwide President, DePuy Synthes Joint Reconstruction
Ian Lawson, Worldwide President, DePuy Mitek
Mark Hanes, Worldwide Director, Hip Development, DePuy Synthes Joint Reconstruction
Hannah McEwen, Worldwide Director, Knee Product
Development, DePuy Synthes Joint Reconstruction
NO. OF EMPLOYEES: 6,500
GLOBAL HEADQUARTERS: Warsaw, Ind. & Raynham, Mass.
It’s safe to say that for the Medical Devices and Diagnostics division of global healthcare powerhouse Johnson & Johnson—which is responsible for approximately 41 percent of the company’s sales, the big news in fiscal 2012 (ended Dec. 31)—was the completion of the long-awaited purchase of Switzerland’s Synthes Inc., a boon for the company’s DePuy orthopedic division. The deal was announced in April 2011 and was closed in June last year.
By the time all the antitrust requirements were settled on both sides of the Atlantic, the final price for the company was $19.7 billion in cash and stock—the largest in the JNJ’s history. European Union authorities had worried that the deal would make JNJ untouchable in the already concentrated $5.5 billion trauma device market. To make regulators happy, JNJ sold DePuy’s trauma holdings. In April 2012, Biomet Inc. stepped up as the buyer—to the tune of $280 million.
Even after divesting it’s trauma business to Biomet, JNJ’s blockbuster Synthes deal, which created the DePuy Synthes Companies of Johnson & Johnson, will have the majority share of the trauma market. Before the buyout, Synthes already had cornered 50 percent of the market for screws, plates, bone grafts and other products to treat skeletal injuries. Analysts claimed that JNJ’s primary interest in Synthes was the company’s spinal technology. Like many other large companies, Johnson & Johnson has been looking for key acquisitions to bolster sales and expand in new markets. Since the start of 2010, JNJ has had more than 50 drug and devices recalls. The recalls have cost the company around $900 million in annual sales, which resulted in pressure to find new revenue drivers and earnings growth.
“The completion of the Synthes acquisition creates the world’s most innovative and comprehensive orthopedics business and reflects our long-standing strategy of leadership within attractive health care markets,” said Alex Gorsky, JNJ’s CEO, only in his job a few months at the time. “The combination of these two leaders—Synthes and DePuy—will enable us to better serve clinicians and patients worldwide, bring new innovations to the marketplace in orthopedics and neurologics, and strengthen our ability to compete in developing markets.”
Gorsky was named JNJ’s CEO in February 2012.
With a number of recall and quality issues plaguing the New Brunswick, N.J.-based healthcare conglomerate across all of its businesses, few analysts were surprised to learn that the company appointed a new chief executive. Gorsky, a former army captain and endurance athlete has spent two decades at JNJ, most recently leading the Medical Devices and Diagnostics Group.
Former CEO William Weldon had been blamed for much of JNJ’s troubles. He became CEO in 2002 after spending his entire career at the company. Critics accused Weldon of allowing JNJ’s once-staunch attention to quality erode through the years, resulting in, among other things, metal-on-metal hips that wore out and failed long before they should have. At the time of his departure, JNJ’s DePuy unit faced more than 4,500 lawsuits over the ASR XL Acetabular System, a hip socket used in traditional replacement surgery, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur to preserve more bone. Both products were recalled in August 2010. As of early 2012, JNJ had recalled 93,000 hips worldwide, including 37,000 in the United States, warning that more than 12 percent failed within five years.
After taking the reins of the venerable firm, Gorsky became only the ninth CEO in JNJ’s 126-year history. He joined JNJ’s Janssen Pharmaceuticals unit in 1988 as a sales representative and then worked in various positions in sales, marketing and management during the next 15 years. In 2001, Gorsky became president of Janssen and was promoted two years later to company group chairman of JNJ’s pharmaceuticals business in Europe, the Middle East and Africa. Gorsky left JNJ in 2004 to become head of North American pharmaceuticals for Basel, Switzerland-based Novartis AG. He returned four years later, however, as company group chairman and worldwide franchise chairman for Ethicon in the medical devices business. In 2009, Gorsky was appointed worldwide chairman of the surgical care group and to JNJ’s executive committee.
Some critics feel JNJ should have looked outside for its leadership.
Michael A. Kelly, a San Francisco, Calif.-based attorney suing the company, said he was shocked by JNJ’s change in leadership.
“It’s clear that the medical device division was not being well supervised, managed or run, certainly from 2006 through 2010, when the entire ASR debate was going forward,” Kelly, of Walkup, Melodia, Kelly & Shoenberger, noted to Bloomberg reporters. “I would think somebody would say at what cost are we making the profits and what message does it send that we promote the person who was in charge of this division to an even higher job, given the way that the entire ASR issue was handled.”
Gorsky holds a Bachelor of Science degree from the U.S. Military Academy at West Point, N.Y., and spent six years in the U.S. Army. In 1996, he earned a Master of Business Administration from the Wharton School of the University of Pennsylvania. In addition to his role as CEO, Gorsky was named company chairman in November 2012.
Given the size and scope of the DePuy Synthes product line, a long list of new product rollouts is business as usual. FY12 was no exception.
DePuy Orthopaedics Inc., prior to the Synthes merger, received U.S. Food and Drug Administration (FDA) premarket approval for its Trumatch Personalized Solutions with DePuy’s Sigma RP knee system. TruMatch for use with DePuy’s Sigma Fixed Bearing knee previously was cleared in August 2011. TruMatch is a surgical instrumentation and computer software system that is designed to aid knee implant positioning and procedure efficiency. It uses CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. CT scans, rather than MRIs, are used for improved bone imaging, less scanning time and lower costs. Later, in November 2012, the company received FDA 510(k) clearance for its TruMatch Pin Guide, which is designed to give surgeons the option of choosing a pin guide or a cutting guide in their procedures. According to the company, it offers surgeons intra-operative flexibility; a smaller, lower profile jig for less invasive procedures; an integrated alignment guide to improve ease of use; and reusable, re-sterilizable metal guides for pin drilling. TruMatch Personalized Solutions originally launched in 2009.
In October, DePuy Synthes Spine rolled out new image-guided instrumentation for two of its spine systems as part of a partnership agreement with Brainlab for surgical navigation and imaging solutions. The new system is designed to be used with the Viper 2 Pedicle Screw Fixation System for minimally invasive surgery and Expedium Spine System for open surgical procedures. The instrumentation, which includes awls, probes, taps, screw inserters and Jamshidi needles, has been integrated with Brainlab’s computer software. Additional image guided and surgical navigation systems are expected over the next several months. Based in Germany, Brainlab develops, manufactures and markets software-driven medical technology.
Also in October, during the annual meeting of the North American Spine Society, the company released its ACIS Anterior Cervical Interbody Spacer System, a set of spacers and instrumentation for anterior cervical discectomy and fusion. The company also launched the Spotlight PL Access System, which the firm claims is the first access system designed specifically for minimally invasive posterior-lateral fusion. ACIS System spacers are offered in three axial footprints (12.5, 14 or 16 millimeter widths), eight heights (5-12 millimeters) and three sagittal profiles (lordotic, parallel or convex) to accommodate individual patient anatomy and surgical techniques. The spacers are made of PEEK Optima (polyetheretherketone) radiolucent material and feature a large axial lumen to maximize the area for packing autogenous bone graft and enable fusion to occur through the spacer, according to the company. The ACIS system is intended for use with supplemental fixation.
The Spotlight system includes a set of retractors of various lengths with integrated fiber optic lighting and decortication instruments, all of which are designed for use with the company's Viper 3D MIS Correction Set.
“This new retractor delivers the benefits of a minimally invasive approach to posterior lateral fusion. Spotlight PL System provides excellent visibility and allows me to perform up to a four-level posterior lateral fusion through only one incision,” according to Amer Samdani, M.D., a physician at Shriners Hospitals for Children in Philadelphia, Pa., and also a paid consultant to the company.
Posterior-lateral fusion, a procedure where surgeons place graft material along the sides of the vertebrae to stimulate bone growth and promote fusion, is used to treat conditions including degenerative disc disease, spinal stenosis, scoliosis and other complex spinal deformities.
In yet another October rollout, DePuy Orthopaedics Inc. made the Sigma high-performance revision instruments available for use with its Sigma fixed-bearing total knee implants. The instruments are designed for increased efficiency in the operating room. According to the company, the revision instruments can reduce the average number of instrument cases required during surgery by 40 percent versus leading competitive systems, combined with a 70 percent reduction in tibial preparation steps versus other systems. The system reportedly also incorporates visual cues and easy adjustments on the cutting blocks and a simplified trialing system to allow surgeons to increase efficiency throughout the procedure.
“The number of sets and trays traditionally needed for revision knee procedures can lead to inefficiency and additional costs in the operating room,” said Andrew Ekdahl, worldwide president of DePuy Orthopaedics. “Reducing the number of instrument cases by nearly half and the number of steps required to prep the tibia by 70 percent could lead to a more efficient surgery—and that’s better for the patient and better for the healthcare system.”
The top reasons revision knee implants fail are loosening and instability. DePuy has attempted to address these problems with its revision instruments, which include the Sigma rotating platform knee and the Sigma metaphyseal sleeves. The rotating platform features a mobile bearing option for every constraint level. Revision knees using rotating platform technology diffuse shear and torsional forces typically produced at the implant bone interface, DePuy officials claim. Metaphyseal sleeves are stepped sleeves designed to compensate for substantial type 2 and 3 cavitary defects, while bringing the implant into contact with strong, supportive bone. The sleeve is stepped to compressively load the bone and form a stronger foundation for implant stability, potentially avoiding excessive bone resection and restoring the joint line.
DePuy’s prolific October kicked off with its Mitek division—manufacturer of orthopedic sports medicine products and soft tissue repair devices—releasing the Healix Advance family of suture anchors, a comprehensive new system of rotator cuff anchor and instrumentation solutions.
According to the American Academy of Orthopaedic Surgeons, each year approximately 200,000 Americans require rotator cuff repair surgery and another 400,000 undergo procedures to fix rotator cuff tendonitis or partial tears.
The Healix Advance Anchor includes the dual-thread fixation technology of previous versions, but adds a new multi-thread design that reportedly enables faster insertion into hard bone and an awl only bone preparation, in most cases. Dual thread technology is designed to independently engage both cancellous (spongy) and cortical (compact) bone to maximize fixation and pull-out strength.
According to the company, Healix Advance Anchors have a newly designed and fully supported distal tip across the radial plane, and also provide high torsional strength across the entire length of the anchor. The anchors are available either in Biocryl Rapide, a biocomposite material intended to allow absorption and bone formation at the implant site, or radiolucent PEEK. The 4.5 mm, 5.5 mm and 6.5 mm anchors are double- or triple-loaded with the company’s Orthochord High Strength Suture.
The first Healix Anchor was introduced in 2008. Since then the company has added Healix Knotless, Healix Transtend, and now, Healix Advance Anchors.
In August, DePuy Synthes Spine received FDA 510(k) clearance for its Expedium, Viper, and Viper 2 Spine Systems for patients with adolescent idiopathic scoliosis (AIS), an abnormal curvature of the spine that typically affects children between the ages of 10 and 18. This expands the scoliosis indication for the pedicle screw systems, which now are indicated for both adolescents and adults. The Expedium technology first was introduced in 2004. The Viper and Viper 2 Spine Systems have been used in minimally invasive spine surgery for a wide range of pathologies since 2005 and 2008 respectively.
The Expedium system has the lowest profile in the DePuy Synthes’ thoracolumbar portfolio, and therefore is claimed to be a useful option for cases in which the surgeon is challenged with implant protrusion and cosmetic problems, according to the company. It is a rod and screw system for extreme curvatures. The Viper systems comprise a range of instrumentation and implant options, and are based on the Expedium platform.
“AIS is a serious challenge to surgeons, patients, and their families,” said Suken Shah, M.D., spine surgeon at the Alfred I. DuPont Hospital for Children in Wilmington, Del. “New treatment options based on proven technologies provide surgeons with more choices to help more patients.”
Scoliosis can lead to chronic back pain and reduced respiratory function, and impact quality of life by limiting activity and affecting self-esteem. If the curvature of the spine is between 25 to 45 degrees, back bracing is generally recommended in an attempt to stop curve progression. If the curve progresses beyond 45 degrees, spinal fusion surgery is considered to strengthen and straighten the spine. Most patients do not progress to a degree needing surgical intervention. According to the National Scoliosis Foundation, scoliosis patients make more than 600,000 visits to private physician offices, 38,000 children undergo spinal fusion surgeries and about 30,000 children are braced each year in the United States.
Abrupt Departure
In December, DePuy Synthes named Max Reinhardt worldwide president of DePuy Synthes Spine. He has been with the company since 2002, serving as vice president of worldwide marketing prior to his latest appointment, a post he’d held since early 2011. Reinhardt began his career with DePuy Spine in 2002 as director of sales and marketing in the United Kingdom. Four years later he became vice president of sales in the United States. When Johnson & Johnson completed its acquisition of Synthes, Reinhardt was charged with helping to integrate the global spine divisions of both companies. The spine unit’s former chief, Namal Nawana, resigned unexpectedly on Nov. 27. Nawana joined DePuy Spine as president in March 2011. He started his career in 1992 as a research engineer at Royal Adelaide Hospital in Australia, and then moved on to Howmedica International as a product development engineer. He joined JNJ’s orthopedics business in 1997 as a technical support manager in the United Kingdom and worked his way up the management ladder.
The Bottom Line
JNJ’s worldwide medical device and diagnostics sales were $27.4 billion for 2012—an increase of 6.4 percent compared with 2011, factoring an operational increase of 8.7 percent and a decrease from currency of 2.3 percent. Domestic sales increased 8.7 percent; international sales increased 4.5 percent, which reflected an operational increase of 8.6 percent and a negative currency effect of 4.1 percent. Sales, of course, included the impact of the recently completed acquisition of Synthes, which contributed 7.9 percent to worldwide operational sales growth, including the divestiture of the DePuy trauma business.
The orthopedics franchise achieved sales of $7.8 billion in 2012, a 34.3 percent increase from 2011. Growth primarily was due to sales of newly acquired products from Synthes, and sales of joint reconstruction and Mitek sports medicine products. The positive impact on the orthopedics franchise total sales growth and operational growth due to the newly acquired products from Synthes, including the trauma business sale, was 34.7 percent.
Pre-tax profits for the medical device businesses were roughly $7.2 billion, an increase of 37 percent—once again, the Synthes deal helped to substantially grow that number. For JNJ overall, sales were $67.2 billion, up from $65 billion in 2011. Net earnings were $10.5 billion, up from $9.7 billion the year before. U.S. and international sales both increased.
$7.8 Billion
KEY EXECUTIVES:
Alex Gorsky, CEO & Chairman, JNJ
Dominic J. Caruso, VP, Finance & CFO, JNJ
Charles E. Austin, VP, Global Supply Chain, JNJ
Karen A. Licitra, Chairman, Global Medical Solutions Group, JNJ
Michel Orsinger, Worldwide Chairman, DePuy Synthes Companies
Gary Fischetti, Group Chairman, Orthopaedic Group, DePuy Synthes
Max Reinhardt, Worldwide President, DePuy Synthes Spine
Andrew Ekdahl, Worldwide President, DePuy Synthes Joint Reconstruction
Ian Lawson, Worldwide President, DePuy Mitek
Mark Hanes, Worldwide Director, Hip Development, DePuy Synthes Joint Reconstruction
Hannah McEwen, Worldwide Director, Knee Product
Development, DePuy Synthes Joint Reconstruction
NO. OF EMPLOYEES: 6,500
GLOBAL HEADQUARTERS: Warsaw, Ind. & Raynham, Mass.
It’s safe to say that for the Medical Devices and Diagnostics division of global healthcare powerhouse Johnson & Johnson—which is responsible for approximately 41 percent of the company’s sales, the big news in fiscal 2012 (ended Dec. 31)—was the completion of the long-awaited purchase of Switzerland’s Synthes Inc., a boon for the company’s DePuy orthopedic division. The deal was announced in April 2011 and was closed in June last year.
By the time all the antitrust requirements were settled on both sides of the Atlantic, the final price for the company was $19.7 billion in cash and stock—the largest in the JNJ’s history. European Union authorities had worried that the deal would make JNJ untouchable in the already concentrated $5.5 billion trauma device market. To make regulators happy, JNJ sold DePuy’s trauma holdings. In April 2012, Biomet Inc. stepped up as the buyer—to the tune of $280 million.
Even after divesting it’s trauma business to Biomet, JNJ’s blockbuster Synthes deal, which created the DePuy Synthes Companies of Johnson & Johnson, will have the majority share of the trauma market. Before the buyout, Synthes already had cornered 50 percent of the market for screws, plates, bone grafts and other products to treat skeletal injuries. Analysts claimed that JNJ’s primary interest in Synthes was the company’s spinal technology. Like many other large companies, Johnson & Johnson has been looking for key acquisitions to bolster sales and expand in new markets. Since the start of 2010, JNJ has had more than 50 drug and devices recalls. The recalls have cost the company around $900 million in annual sales, which resulted in pressure to find new revenue drivers and earnings growth.
“The completion of the Synthes acquisition creates the world’s most innovative and comprehensive orthopedics business and reflects our long-standing strategy of leadership within attractive health care markets,” said Alex Gorsky, JNJ’s CEO, only in his job a few months at the time. “The combination of these two leaders—Synthes and DePuy—will enable us to better serve clinicians and patients worldwide, bring new innovations to the marketplace in orthopedics and neurologics, and strengthen our ability to compete in developing markets.”
Gorsky was named JNJ’s CEO in February 2012.
With a number of recall and quality issues plaguing the New Brunswick, N.J.-based healthcare conglomerate across all of its businesses, few analysts were surprised to learn that the company appointed a new chief executive. Gorsky, a former army captain and endurance athlete has spent two decades at JNJ, most recently leading the Medical Devices and Diagnostics Group.
Former CEO William Weldon had been blamed for much of JNJ’s troubles. He became CEO in 2002 after spending his entire career at the company. Critics accused Weldon of allowing JNJ’s once-staunch attention to quality erode through the years, resulting in, among other things, metal-on-metal hips that wore out and failed long before they should have. At the time of his departure, JNJ’s DePuy unit faced more than 4,500 lawsuits over the ASR XL Acetabular System, a hip socket used in traditional replacement surgery, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur to preserve more bone. Both products were recalled in August 2010. As of early 2012, JNJ had recalled 93,000 hips worldwide, including 37,000 in the United States, warning that more than 12 percent failed within five years.
After taking the reins of the venerable firm, Gorsky became only the ninth CEO in JNJ’s 126-year history. He joined JNJ’s Janssen Pharmaceuticals unit in 1988 as a sales representative and then worked in various positions in sales, marketing and management during the next 15 years. In 2001, Gorsky became president of Janssen and was promoted two years later to company group chairman of JNJ’s pharmaceuticals business in Europe, the Middle East and Africa. Gorsky left JNJ in 2004 to become head of North American pharmaceuticals for Basel, Switzerland-based Novartis AG. He returned four years later, however, as company group chairman and worldwide franchise chairman for Ethicon in the medical devices business. In 2009, Gorsky was appointed worldwide chairman of the surgical care group and to JNJ’s executive committee.
Some critics feel JNJ should have looked outside for its leadership.
Michael A. Kelly, a San Francisco, Calif.-based attorney suing the company, said he was shocked by JNJ’s change in leadership.
“It’s clear that the medical device division was not being well supervised, managed or run, certainly from 2006 through 2010, when the entire ASR debate was going forward,” Kelly, of Walkup, Melodia, Kelly & Shoenberger, noted to Bloomberg reporters. “I would think somebody would say at what cost are we making the profits and what message does it send that we promote the person who was in charge of this division to an even higher job, given the way that the entire ASR issue was handled.”
Gorsky holds a Bachelor of Science degree from the U.S. Military Academy at West Point, N.Y., and spent six years in the U.S. Army. In 1996, he earned a Master of Business Administration from the Wharton School of the University of Pennsylvania. In addition to his role as CEO, Gorsky was named company chairman in November 2012.
Given the size and scope of the DePuy Synthes product line, a long list of new product rollouts is business as usual. FY12 was no exception.
DePuy Orthopaedics Inc., prior to the Synthes merger, received U.S. Food and Drug Administration (FDA) premarket approval for its Trumatch Personalized Solutions with DePuy’s Sigma RP knee system. TruMatch for use with DePuy’s Sigma Fixed Bearing knee previously was cleared in August 2011. TruMatch is a surgical instrumentation and computer software system that is designed to aid knee implant positioning and procedure efficiency. It uses CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. CT scans, rather than MRIs, are used for improved bone imaging, less scanning time and lower costs. Later, in November 2012, the company received FDA 510(k) clearance for its TruMatch Pin Guide, which is designed to give surgeons the option of choosing a pin guide or a cutting guide in their procedures. According to the company, it offers surgeons intra-operative flexibility; a smaller, lower profile jig for less invasive procedures; an integrated alignment guide to improve ease of use; and reusable, re-sterilizable metal guides for pin drilling. TruMatch Personalized Solutions originally launched in 2009.
In October, DePuy Synthes Spine rolled out new image-guided instrumentation for two of its spine systems as part of a partnership agreement with Brainlab for surgical navigation and imaging solutions. The new system is designed to be used with the Viper 2 Pedicle Screw Fixation System for minimally invasive surgery and Expedium Spine System for open surgical procedures. The instrumentation, which includes awls, probes, taps, screw inserters and Jamshidi needles, has been integrated with Brainlab’s computer software. Additional image guided and surgical navigation systems are expected over the next several months. Based in Germany, Brainlab develops, manufactures and markets software-driven medical technology.
Also in October, during the annual meeting of the North American Spine Society, the company released its ACIS Anterior Cervical Interbody Spacer System, a set of spacers and instrumentation for anterior cervical discectomy and fusion. The company also launched the Spotlight PL Access System, which the firm claims is the first access system designed specifically for minimally invasive posterior-lateral fusion. ACIS System spacers are offered in three axial footprints (12.5, 14 or 16 millimeter widths), eight heights (5-12 millimeters) and three sagittal profiles (lordotic, parallel or convex) to accommodate individual patient anatomy and surgical techniques. The spacers are made of PEEK Optima (polyetheretherketone) radiolucent material and feature a large axial lumen to maximize the area for packing autogenous bone graft and enable fusion to occur through the spacer, according to the company. The ACIS system is intended for use with supplemental fixation.
The Spotlight system includes a set of retractors of various lengths with integrated fiber optic lighting and decortication instruments, all of which are designed for use with the company's Viper 3D MIS Correction Set.
“This new retractor delivers the benefits of a minimally invasive approach to posterior lateral fusion. Spotlight PL System provides excellent visibility and allows me to perform up to a four-level posterior lateral fusion through only one incision,” according to Amer Samdani, M.D., a physician at Shriners Hospitals for Children in Philadelphia, Pa., and also a paid consultant to the company.
Posterior-lateral fusion, a procedure where surgeons place graft material along the sides of the vertebrae to stimulate bone growth and promote fusion, is used to treat conditions including degenerative disc disease, spinal stenosis, scoliosis and other complex spinal deformities.
In yet another October rollout, DePuy Orthopaedics Inc. made the Sigma high-performance revision instruments available for use with its Sigma fixed-bearing total knee implants. The instruments are designed for increased efficiency in the operating room. According to the company, the revision instruments can reduce the average number of instrument cases required during surgery by 40 percent versus leading competitive systems, combined with a 70 percent reduction in tibial preparation steps versus other systems. The system reportedly also incorporates visual cues and easy adjustments on the cutting blocks and a simplified trialing system to allow surgeons to increase efficiency throughout the procedure.
“The number of sets and trays traditionally needed for revision knee procedures can lead to inefficiency and additional costs in the operating room,” said Andrew Ekdahl, worldwide president of DePuy Orthopaedics. “Reducing the number of instrument cases by nearly half and the number of steps required to prep the tibia by 70 percent could lead to a more efficient surgery—and that’s better for the patient and better for the healthcare system.”
The top reasons revision knee implants fail are loosening and instability. DePuy has attempted to address these problems with its revision instruments, which include the Sigma rotating platform knee and the Sigma metaphyseal sleeves. The rotating platform features a mobile bearing option for every constraint level. Revision knees using rotating platform technology diffuse shear and torsional forces typically produced at the implant bone interface, DePuy officials claim. Metaphyseal sleeves are stepped sleeves designed to compensate for substantial type 2 and 3 cavitary defects, while bringing the implant into contact with strong, supportive bone. The sleeve is stepped to compressively load the bone and form a stronger foundation for implant stability, potentially avoiding excessive bone resection and restoring the joint line.
DePuy’s prolific October kicked off with its Mitek division—manufacturer of orthopedic sports medicine products and soft tissue repair devices—releasing the Healix Advance family of suture anchors, a comprehensive new system of rotator cuff anchor and instrumentation solutions.
According to the American Academy of Orthopaedic Surgeons, each year approximately 200,000 Americans require rotator cuff repair surgery and another 400,000 undergo procedures to fix rotator cuff tendonitis or partial tears.
The Healix Advance Anchor includes the dual-thread fixation technology of previous versions, but adds a new multi-thread design that reportedly enables faster insertion into hard bone and an awl only bone preparation, in most cases. Dual thread technology is designed to independently engage both cancellous (spongy) and cortical (compact) bone to maximize fixation and pull-out strength.
According to the company, Healix Advance Anchors have a newly designed and fully supported distal tip across the radial plane, and also provide high torsional strength across the entire length of the anchor. The anchors are available either in Biocryl Rapide, a biocomposite material intended to allow absorption and bone formation at the implant site, or radiolucent PEEK. The 4.5 mm, 5.5 mm and 6.5 mm anchors are double- or triple-loaded with the company’s Orthochord High Strength Suture.
The first Healix Anchor was introduced in 2008. Since then the company has added Healix Knotless, Healix Transtend, and now, Healix Advance Anchors.
In August, DePuy Synthes Spine received FDA 510(k) clearance for its Expedium, Viper, and Viper 2 Spine Systems for patients with adolescent idiopathic scoliosis (AIS), an abnormal curvature of the spine that typically affects children between the ages of 10 and 18. This expands the scoliosis indication for the pedicle screw systems, which now are indicated for both adolescents and adults. The Expedium technology first was introduced in 2004. The Viper and Viper 2 Spine Systems have been used in minimally invasive spine surgery for a wide range of pathologies since 2005 and 2008 respectively.
The Expedium system has the lowest profile in the DePuy Synthes’ thoracolumbar portfolio, and therefore is claimed to be a useful option for cases in which the surgeon is challenged with implant protrusion and cosmetic problems, according to the company. It is a rod and screw system for extreme curvatures. The Viper systems comprise a range of instrumentation and implant options, and are based on the Expedium platform.
“AIS is a serious challenge to surgeons, patients, and their families,” said Suken Shah, M.D., spine surgeon at the Alfred I. DuPont Hospital for Children in Wilmington, Del. “New treatment options based on proven technologies provide surgeons with more choices to help more patients.”
Scoliosis can lead to chronic back pain and reduced respiratory function, and impact quality of life by limiting activity and affecting self-esteem. If the curvature of the spine is between 25 to 45 degrees, back bracing is generally recommended in an attempt to stop curve progression. If the curve progresses beyond 45 degrees, spinal fusion surgery is considered to strengthen and straighten the spine. Most patients do not progress to a degree needing surgical intervention. According to the National Scoliosis Foundation, scoliosis patients make more than 600,000 visits to private physician offices, 38,000 children undergo spinal fusion surgeries and about 30,000 children are braced each year in the United States.
Abrupt Departure
In December, DePuy Synthes named Max Reinhardt worldwide president of DePuy Synthes Spine. He has been with the company since 2002, serving as vice president of worldwide marketing prior to his latest appointment, a post he’d held since early 2011. Reinhardt began his career with DePuy Spine in 2002 as director of sales and marketing in the United Kingdom. Four years later he became vice president of sales in the United States. When Johnson & Johnson completed its acquisition of Synthes, Reinhardt was charged with helping to integrate the global spine divisions of both companies. The spine unit’s former chief, Namal Nawana, resigned unexpectedly on Nov. 27. Nawana joined DePuy Spine as president in March 2011. He started his career in 1992 as a research engineer at Royal Adelaide Hospital in Australia, and then moved on to Howmedica International as a product development engineer. He joined JNJ’s orthopedics business in 1997 as a technical support manager in the United Kingdom and worked his way up the management ladder.
The Bottom Line
JNJ’s worldwide medical device and diagnostics sales were $27.4 billion for 2012—an increase of 6.4 percent compared with 2011, factoring an operational increase of 8.7 percent and a decrease from currency of 2.3 percent. Domestic sales increased 8.7 percent; international sales increased 4.5 percent, which reflected an operational increase of 8.6 percent and a negative currency effect of 4.1 percent. Sales, of course, included the impact of the recently completed acquisition of Synthes, which contributed 7.9 percent to worldwide operational sales growth, including the divestiture of the DePuy trauma business.
The orthopedics franchise achieved sales of $7.8 billion in 2012, a 34.3 percent increase from 2011. Growth primarily was due to sales of newly acquired products from Synthes, and sales of joint reconstruction and Mitek sports medicine products. The positive impact on the orthopedics franchise total sales growth and operational growth due to the newly acquired products from Synthes, including the trauma business sale, was 34.7 percent.
Pre-tax profits for the medical device businesses were roughly $7.2 billion, an increase of 37 percent—once again, the Synthes deal helped to substantially grow that number. For JNJ overall, sales were $67.2 billion, up from $65 billion in 2011. Net earnings were $10.5 billion, up from $9.7 billion the year before. U.S. and international sales both increased.