03.13.09
According to a recent report, there may not be enough orthopedic surgeons in the near future to provide joint replacements to all who need them. Two new studies presented at this year’s annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) claim that the number of patients requiring hip or knee replacement surgery is likely to soon outpace the number of surgeons who can perform the procedure.
According to a study co-authored by Thomas K. Fehring, M.D., if the number of orthopedic surgeons able to perform total joint replacements continues at its current rate, in 2016, 46 percent of needed hip replacements and 72 percent of knee replacements will not be able to be completed.
“I was somewhat shocked at the shortfall that we predicted,” said Dr. Fehring, an orthopedic surgeon at OrthoCarolina Hip and Knee Center in Charlotte, N.C. “This is life-changing surgery, offering patients the chance to be mobile, and a very high percentage of patients may not be able to receive it.”
Joint replacement, also known as arthroplasty, is considered by many to be one of the most successful medical innovations of the 20th century. Total joint replacement is a surgical procedure in which the patient’s natural joint is replaced with an artificial one.
More than 700,000 primary total hip and knee replacements are performed each year in the United States, and demand for the surgery is expected to double in the next 10 years.
A second study co-authored by Steven M. Kurtz, Ph.D., found that a major reason for the growth in patient demand for joint replacement is the increase in younger patients.
According to AAOS, projections show that by 2011, more than 50 percent of patients requiring hip replacements will be under the age of 65; the knee-replacement patient population will reach that threshold by 2016. For primary total knee replacement, the fastest growing group of patients is in the 45-54 age category; the number of procedures performed in this age group is projected to grow from 59,077 in 2006 to 994,104 (an increase of 17 times) by 2030.
“Joint replacement is generally thought of as a procedure for older people, over 65,” said Kurtz, corporate vice president and office director at Exponent, Inc., an engineering and scientific consulting firm in Philadelphia, Pa. “Our projections show that younger people make up a big piece of the pie, and that is only going to increase if historical trends continue.”
Both researchers believe that the key to stemming this supply-side crisis is for policymakers to reconsider the rates at which total joint replacements are reimbursed. The reimbursement rates have consistently gone down over the years, even as the costs of providing health care have gone up. However, they noted that the possibility of new technologies may offer a glimmer of hope.
“It’s hard to predict what changes will come about in the next 20 years,” he said. “Hopefully, we will have some new tools in the future to help address this problem, which could be of epidemic proportions.”
Medtech Execs Back Comparing Treatments
During a recent conference call organized by the Advanced Medical Tech-nology Association (AdvaMed) in Wash-ington, D.C., medical device industry executives voiced their support for a comparative effectiveness program that received $1.1 billion in the recently passed economic stimulus bill.
Executives on the call gave their thumbs-up, provided the program doesn’t always result in the cheapest method used and innovation isn’t discouraged.
Comparative effectiveness measures cost effectiveness and clinical benefits of competing treatments. Historically, when companies came up with a new technology or drug to deliver care, all they had to produce was clinical data to show its efficacy. Now, the Comparative Effectiveness Institute, a new regulatory body, may be created to evaluate economic data—in other words, how much the new technology would cost Medicare and how much cost savings it would bring over the long term.
“We can’t afford a cheapest-at-best approach to medicine,” said Bill Haw-kins, chairman and CEO of Minneapolis, Minn.-based Medtronic Inc. “Cheapest in the short run is not necessarily the best value for patients over the long term.”
Executives from Edwards Lifesciences Corp., Becton Dickinson & Co., Advanced Medical Optics Inc., Medtronic and other device companies said they want to make sure their voices are heard on healthcare changes.
Steve Ubl, president of AdvaMed, said the industry is concerned that putting a focus on healthcare costs will result in the stifling of medical innovation. “We must guard against an innovation blind spot,” Ubl said.
He cited a University of Chicago study that found the economic benefits to continued advancements in medical technology are substantial.
He noted improvement in life expectancy from cardiovascular care added about $2.6 trillion per year to the national wealth from 1970 to 1998.
The FDA’s oversight of the medical device industry has been under scrutiny recently. A group of agency scientists wrote to then-President elect Barack Obama and members of Congress about how the medical device approval process is flawed. The Government Accountability Office, the investigative arm of Congress, issued a report last month saying some of the most risky medical devices were not carefully reviewed by the FDA before they went on the market, and that the agency should take corrective action swiftly.
Medtronic’s Hawkins denied that legislators and other industry stakeholders are at odds over the issue of comparative effectiveness, which may increase the cost burden on companies developing new therapies and devices.
“I would comment that in fact that we have endorsed the concept of comparative effectiveness and in fact it is very much what our industry does every day when we go and present our products and comparing what we do versus other products,” Hawkins said.
AAOS Annual Meeting: Product Announcements
Orthopedic device companies unveiled a variety of new products at the American Association of Orthopaedic Surgeons’ (AAOS) 76th annual meeting in Las Vegas, Nev. The event took place Feb. 25-28 at the Venetian Las Vegas Hotel Casino.
Based on feedback from some device companies, it seems the orthopedic reconstruction market remains relatively stable, at least through early this year.
Industry executives, however, still remain cautiously optimistic about full-year results. Johnson & Johnson’s DePuy division is projecting 6 percent to 8 percent market growth this year. Zimmer continues to forecast 6 percent constant currency global market growth for 2009, slightly down compared with last years, but consistent with its fourth-quarter comments. Many doctors reported experiencing some slowdown in procedures and expect procedure growth to slow further.
On the innovation front, some noteworthy product announcements came from the following companies:
• MAKO Surgical Corp., based in Fort Lauderdale, Fla., unveiled the next generation of its robotic arm system and implants used for the company’s MAKOplasty partial knee resurfacing system. MAKO’s robotic arm system is the first FDA-cleared robotic arm system for orthopedic surgery, the company said. The Robotic Arm Interactive Orthopedic System—called RIO—and the Restoris MCK multi-compartmental knee system makes bone-and tissue- sparing MAKOplasty partial knee resurfacing available to a larger number of patients, according to the company. Before the development of the robotic arm system, surgeons could perform precision resurfacing surgery only on the medial (inner) portion of the knee. The robotic system, however, enables surgeons to perform the surgery on the medial, patellofemoral (top) or both components of the knee, offering a large and growing population of patients with early to mid-stage osteoarthritis of the knee a less-invasive treatment option than total knee replacement.
• London, United Kingdom-based Smith & Nephew Inc., (U.S. headquarters in Memphis, Tenn.), unveiled several new products, including:
A patient-matched instrumentation technology for total knee replacement surgery. Dubbed Visionaire, the technology uses a patient’s MRI and X-rays to develop custom surgical instruments that can be used with the company’s knee implants. The disposable, patient-specific instruments enable surgeons to eliminate multiple steps and shave minutes from knee replacement surgery, cutting the risk of infection as well as the amount of time a patient is under anesthesia, according to the company. The system also helps hospitals reduce expenses by eliminating sterilization costs associated with the traditional, reusable instruments it replaces. Visionaire technology received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in November and will be launched in targeted U.S. markets throughout 2009.
The company’s Orthopaedic Recon-struction & Trauma division introduced a metal liner option for its R3 Acetabular System, a multi-bearing acetabular cup system used in hip replacement and resurfacing procedures. The metal liner recently was approved by the FDA for use with the company’s Birmingham HipResurfacing System. Since March 2008, the R3 system has been fitted with cross-linked polyethylene liners for use in total hip replacement cases, and Smith & Nephew recently received FDA approval of its ceramic liner option. The multi-bearing cup, in addition to providing intra-operative flexibility for surgeons, is designed to reduce wear and the need for revision surgery. Its range of inserts accommodates larger head sizes and is optimized to help the R3 system achieve joint stability and a greater range of motion. By using disposable trial liners and a single set of instruments for all bearings, the R3 Acetabular System helps simplify operating room procedures, according to the company.
Smith & Nephew’s Endoscopy division launched the Osteoraptor anchor for hip and shoulder repair. The anchor uses polylactic acid hydroxyapatite, a substance whose key ingredient (hydro-xyapatite) is found naturally in bone. Studies have shown that hydroxyapatite helps increase the anchor’s strength and introduces chemicals that promote the formation of a strong bond between the anchor and the bone surface. The anchor is available in 2.3 and 2.9 millimeter sizes. The Osteoraptor 2.3 mm hip anchor is the smallest bioabsorbable hip anchor on the market, company officials claim. Typically, surgeons use multiple anchors to repair labral tears. The anchor gives surgeons the ability to place it more precisely within the tight confines of the joint space.
Smith & Nephew’s orthopedics business and BrainLAB announced an agreement by which BrainLAB will become the exclusive vendor for developing and supporting computer-assisted surgical technologies for Smith & Nephew’s hip and knee implants. Beginning this month, Munich, Germany-based BrainLAB will begin work integrating the Smith & Nephew portfolio of instruments, implants and pre-existing navigation technology into its proprietary systems. The venture will enable BrainLAB to help Smith & Nephew build upon the innovations introduced within the implant maker’s PiGalileo system, according to a statement by the company. For example, the exclusive PiGalileo Acculign motorized positioning guide is expected to play a central role in the future development of the system, according to officials from both firms. Under the agreement, Smith & Nephew will provide marketing, sales support, training, and post-installation clinical support, while BrainLAB will execute sales of the navigation equipment, as well as applications training and service. Smith & Nephew will continue to support its base of existing computer-navigation customers who use its PiGalileo and AchieveCAS systems.
• Globus Medical Inc., based in Audubon, Pa., launched its Independence Spacer System. The system is part of the company’s MILDER (minimally invasive, less disruptive, earlier recovery) anterior lumbar interbody fusion (ALIF) portfolio. Independcnce integrates a stabilization plate and a PEEK interbody spacer into a preassembled, easy-to-use system that enables a less disruptive surgery than a traditional ALIF procedure. The entire procedure is streamlined by low profile instrumentation, which facilitates a less invasive approach through a smaller incision. The elimination of a traditional plate preserves the natural anatomic profile of a patient’s lumbar spine. Independence also incorporates a smooth screw blocking mechanism, minimizing the disruption to the anatomy surrounding the surgical site and possibly minimizing the long-term impact from surgery.
• Florida-based RTI Biologics announced the launch of two new biologic implants for use in sports medicine: the Matrix HD, a dermis graft for sports medicine, and the fresh-stored osteochondral (OC) talus allograft, an expansion of RTI’s fresh OC line. Matrix HD comprises collagenous connective tissue with three-dimensional intertwined fibers that retain the multidirectional and mechanical properties of natural dermis, while providing the basic structure to support a patient’s own tissue regeneration. The implant is offered in multiple sizes to accommodate particular soft tissue defects and surgeons’ needs. For the surgeon, Matrix HD provides a sterile allograft dermis implant to supplement, support, protect and reinforce tissue in augmentation procedures of the rotator cuff, anterior shoulder capsule, patellar tendon, quadriceps tendon and Achilles tendon. RTI is expanding its fresh-stored OC line with the introduction of the fresh-stored OC talus allograft. According to the company, the fresh-stored OC talus enables surgeons to resurface cartilage defects in the ankle with mature hyaline cartilage and healthy subchondral bone in a single procedure. Hyaline cartilage is a specific type of cartilage that has poor healing and repair properties once damaged. When damage to the articular surface occurs, a fresh-stored allograft with viable cartilage cells is preferred for optimal healing rather than a frozen allograft cartilage.
• Curexo Technology Corporation, based in Fremont, Calif., a maker of image-directed robotic products for orthopedic applications, has submitted a premarket notification 510(k) application to the FDA for market clearance of its Robodoc Surgical System for total knee arthroplasty (TKA). This submission follows the company's recently cleared 510(k) for total hip arthroplasty and will offer surgeons an accurate, precise and reproducible surgical technique to prepare the joint during a knee replacement procedure. The process will allow surgeons to preoperatively plan their surgery in a 3-D virtual space and then execute the surgery exactly as planned in the operating theatre, according to company officials.
“We are very pleased to announce the submission of the TKA 510(k) application to the FDA, as it demonstrates that we are moving forward with achieving our goals of providing a world class multi-platform technology,” said Brent D. Mittelstadt, president and CEO of Curexo Technology Corp. “We believe that because of our recent hip application clearance, receiving the TKA market clearance should be granted within a reasonable time frame. Offering this additional application will allow us to build upon relationships that we are establishing as we introduce the Robodoc Surgical System into the U.S. orthopedic community.”
• Warsaw, Ind.-based Zimmer Holdings, Inc. showcased a number of new product launches during AAOS that span the company's portfolio.
“This year we’re particularly excited to present an interactive environment for surgeons to explore our Trabecular Metal technology,” said David Dvorak, president and CEO.
The company showcased what it called its “Trabecular Metal technology experience,” which was intended to provide surgeons and others with an interactive environment to explore the structure, function and physiology of what Zimmer officials claim is the only tantalum-engineered porous implant material. Exclusive to Zimmer, the material replicates the structure of cancellous bone and is conducive to more normal bone formation and bone in-growth.
A variety of other new product launches were displayed, including the DeNovo NT Natural Tissue Graft for the treatment of focal cartilage defects in a variety of anatomic locations; the company’s Natural Nail system, which features anatomic-shaped implants designed to match the normal anatomy of long bones and offer improved fixation; and the Periarticular Elbow Locking Plate system, which offers anatomically contoured plates, optimized screw positions and options to address most fracture types.
“We’re bullish about our industry and are confident surgeons will continue to embrace Zimmer’s unique technology platforms,” Dvorak said.