05.18.12
A strategic venture between an Essex Woodlands-led investor syndicate group and medical technology company Smith & Nephew plc has come to fruition: The pair has launched Bioventus LLC, a new company focused on active orthopedic healing.
Headquartered in Durham, N.C., Bioventus was born out of Smith & Nephew’s former Biologics and Clinical Therapies division, which was formed in 2008 and currently generates about $240 million in revenue worldwide. The spin-off was a “win-win” for employees and shareholders, Bioventus CEO Mark Augusti told Orthopedic Design & Technology.
“If you look at the state of strategy at Smith & Nephew—a global, multinational corporation—it’s trying to focus on growth markets outside the U.S. for its core products. On top of that it’s trying to reinvest into its core areas, which are surgical and implants, both in the wound management area as well as the orthopedic and sports medicine spaces,” he said. “So when you think about the investment dollars that they need, it’s hard to get down and appropriately scale your investments into biologics or active orthopedic healing, like Smith & Nephew would like to. So because they like the space and think it’s important, they found a really great partner that would help invest in that space.”
Bioventus has nearly 500 employees in the United States, mostly people who worked at Smith &
Nephew’s Biologics division, and currently has several products in its portfolio designed to help accelerate bone healing and treat osteoarthritis pain. Any employees from the division outside the United States will remain with Smith & Nephew until the global business is transferred over to Bioventus, which will happen over time as legal and regulatory approvals are obtained.
“Outside the U.S., because of the labor regulations, work councils and a variety of regulations throughout the different countries, we couldn’t do everything all at once,” Augusti said. “So we have secured the assets outside the U.S., and we’ve appointed Smith & Nephew as our distributor. All the people and all the countries that are still selling our products are now just doing it technically as our
distributor, and then over time we’ll work with Smith & Nephew to appropriately transition each country out, and work with the local authorities and local labor groups to make sure we do it in the proper way.”
The transaction has been finalized in the United States.
“Smith & Nephew is providing some transition services support, but we are operating as an independent entity,” Augusti said of the new company’s U.S. operations.
Augusti is a Smith & Nephew veteran, having worked there for seven years. He joined the company in 2005 as general manager of the Trauma division, and in 2006 took the position of president of Biologics & Spine, Orthopaedic Trauma and Clinical Therapies division (the same unit that is now Bioventus). Smith & Nephew has handed over the reigns to someone with experience and a proven track record not only with the company, but also in the business of active orthopedic healing.
What exactly is “active orthopedic healing?” Augusti explains that it’s not a new field but a new way of describing an existing field.
“It’s referred to as orthobiologics, but we call it active healing because studies show we have a mechanism that has a sociological effect in how it stimulates bone healing,” he said. “We want to look at other technologies that will assist the body’s natural healing and regenerative capabilities. Some people talk about regenerative medicine. We just try to brand it a little differently. We like to look at technologies and products that can be delivered locally [to the affected site in the body], whether inpatient or outpatient, and that will help the healing process.”
This “mechanism” Augusti referred to is called Exogen, a system that uses ultrasound signals to accelerate bone healing. It is the only U.S. Food and Drug Administration (FDA)-approved device on the market that uses a low intensity pulsed ultrasound signal for bone healing. It is used for non-union fractures—those that have not healed properly, and certain kinds of stress fractures. A number of clinical studies have shown that Exogen can accelerate the healing of indicated fresh fractures by 38 percent, can heal cortical bone in tibia 58 days faster, and can mend cancellous bone in distal radius 37 days faster. This system currently is Bioventus’ flagship product, but there are others in the portfolio and coming down the pipeline in the future.
Bioventus has some combination products that use joint fluid therapy to treat mild to moderate osteoarthritis pain in patients who do not respond to steroids or analgesics, are younger, or whose injury is not as far along.
“We have the Durolane products outside the U.S., which is a single injection technology,” said Augusti.
“And inside the U.S. we have the Supartz product which is a three- to five-injection regimen. We are pursuing Durolane approval in the U.S., where we’ll be running a clinical trial. We also have a broad, all-joints label in Europe. We’ll be running some small confirmatory trials in Europe over the next couple of years. We’re going to be active with the Exogen technology as well as with our partners on our joint fluid technology. But then, of course, we’ll be looking for other products and technologies that we think can fit into this space, and can help with pain patients.”
Bioventus hopes to have its global business fully transitioned from Smith & Nephew by the end of 2012, but Augusti believes it realistically will be finalized in the first quarter of 2013. Of course, with 2013 comes a whole new ball game if the proposed medical device excise tax is implemented. No device companies want to see this tax materialize, but in the event that it does, it is important to have a game plan.
The Advanced Medical Technology
Association, the Medical Device Manufacturers Association and other stakeholders have pointed to the loss of American jobs, harm to U.S. competitiveness, and stifling of innovation as some of the most detrimental effects of the tax.
“I think they make a very precise argument about the detrimental effects the tax will have on investments in the industry, and really good high-paying jobs,” Augusti noted. “Frankly, there’s a lot of innovation here at home, so I think the tax will have an unfortunate effect on an industry that has been pretty good for domestic business. For us, it’s going to mean we will have to make some tough choices on what we can afford to do in R&D, and what we can afford to invest in the company for our growth areas. We will look at sales outside the U.S. and sales inside the U.S., and think about what makes sense. I think it’s pretty self-explanatory—unfortunately there’s no free lunch, people still want a return on their investment. People still like proper investment positions.”
All in all, Bioventus is gearing up for the device tax just like most other medtech companies: preparing for the worst, but hoping for the best.
The company has a team that should help lead it into a successful future. Nearly all managers have come over from Smith & Nephew to continue in their roles at Bioventus: Alan Donze, vice president (VP) of commercial operations in the Americas; Duncan Fatkin, VP of global marketing and reimbursement; Peter Henderson, VP of compliance; Anthony James, VP of operations and quality; Walter Kwiatek, chief information officer; Leigh Ann Stradford, VP of human resources; and Henry Tung, VP of strategic planning and business development. Among the team, they share experience not only from Smith & Nephew but also from Stryker Corp., Baxter, Pfizer Inc., Boston Scientific Corp., and other medtech powerhouses. Bioventus also has hired Jeanne Forneris from American Medical Systems Inc. and Medtronic Inc. to serve as VP and general counsel.
Bioventus currently is located at the same address in the same building that housed the former Smith & Nephew Biologics division in Durham. The company will continue to maintain a close relationship with Smith & Nephew, which will retain 49 percent ownership of Bioventus. Essex Woodlands and its equity partners Pantheon Ventures LLP, Spindletop Healthcare Capital, Alta Capital Partners, Ampersand Capital Partners, and White Pine Medical, own 51 percent of Bioventus with their investment of $118 million.
European Regulators Clear JNJ Acquisition of Synthes
It worked. After unloading its DePuy Orthopaedics Inc. trauma division to make way for Synthes Inc., Johnson & Johnson (JNJ) has won the approval of European antitrust authorities to go through with the acquisition. DePuy is being acquired by Warsaw, Ind.-headquartered Biomet Inc. JNJ announced its intent to buy Switzerland-based orthopedic device company Synthes nearly a year ago, but European regulators feared the move would give JNJ a virtual monopoly in the orthopedics sector. JNJ wanted to fold Synthes into DePuy Orthopaedics to create, according to the company, possibly the world’s largest orthopedics business.
“The proposed acquisition would remove a competitor from some markets which are already concentrated,” Joaquin Almunia, the antitrust chief in the European Union (EU), said in a prepared statement last fall when regulators began their investigation of the proposed merger. “The commission needs to make sure that effective competition is preserved in order to maintain innovation and prevent harm to patients.”
Facing such scrutiny from the European regulators, JNJ decided to sell its DePuy unit, a compromise that has proven successful.
According to a statement released April 19 by the commission, its concerns were based on “very high combined market shares of the merging entities in these markets, the rather mature character of the products, and the strong position of the AO Foundation, a highly reputed Swiss-based surgeon-led organization with an exclusive relationship with Synthes.”
Though it has been approved, the acquisition still may prove troublesome for JNJ. Synthes has had its fair share of legal trouble—in 2009, the company settled charges with New Jersey prosecutors that its clinical investigators did not disclose their financial interests; and late last year, Synthes sued several former employees and their hiring companies, claiming raids on staff, breaches of confidentiality agreements, and violations of patents. In March, the company and four former executives were sued in California by the families of two patients who died on the operating table allegedly from the misuse of bone cement the company had developed. Several executives who admitted their involvement in an illegal clinical trial of the bone cement have been sent to jail.
DePuy has had its share of troubles as well. The company has been fighting criticism due to the 2010 recall of its metal-on-metal hip implants. The devices gained a lot of attention for leaving metal debris in the implant area. There still are patients currently using the device, and David Floyd, DePuy president at the time of the recall, acknowledged that such use would be a concern.
Now that the acquisition deal has materialized, Synthes’ baggage is now JNJ’s. The healthcare conglomerate, however, hopes to gain a stronghold in the trauma sector that it didn’t have before, so the payoff could be worth it.
“We are pleased that the European Commission has granted conditional clearance of Johnson & Johnson’s acquisition of Synthes,” JNJ spokeswoman Lorie Gawreluk said. “We expect to fulfill our commitment to the Commission with the divestiture of the DePuy Orthopaedics Trauma business to Biomet in the second quarter of 2012.”
The outside date is set at June 25.
The Biomet acquisition of DePuy is valued at $280 million, while Synthes will be sold to JNJ for $21.3 billion.
Water Street to Acquire Orthofix’s Sports Medicine Business
Orthofix International N.V. and Breg Inc. are parting ways.
The orthopedic device manufacturer is selling Breg, its sports medicine business unit, for $157.5 million in cash to Chicago, Ill.-based private equity firm Water Street Healthcare Partners LLC.
Executives expect the sale to be completed in the second fiscal quarter of 2012.
Orthofix will use the $140 million in net proceeds from the sale to pay off debt.
Orthofix, headquartered in Curacao, Netherlands Antilles, acquired California-based Breg in 2003. Breg features a portfolio of bracing and cold therapy products that treat various sports-related conditions.
In an April 24 conference call, Orthofix CEO and President Robert Vaters discussed the reason the company decided to sell Breg.
“It allows us to execute on our strategic focus to develop and deliver innovative repair and regenerative solutions to the spine and orthopedic markets,” he said. “Specifically, our de-leveraging gives us more capacity to invest in the repair and regeneration value proposition and at the same time to deliver gross and operating margin improvement...”
Water Street partner Chris Sweeney said the firm would “leverage [the] team’s deep medical products knowledge, extensive operating experience and network of relationships to strategically expand Breg’s innovative products and global presence.”
Upon the sale’s closing, Orthofix will file the required documents with the Securities and Exchange Commission, including any impact of pre-closing liabilities the company will retain.
Founded in 1980, Orthofix develops trauma and spinal fusion products. Its North American headquarters is located in Lewisville, Texas. Water Street invests in companies focused in medical and diagnostic products, specialty distribution, outsourced healthcare services, and specialty pharmaceutical products and services.
New AdvaMed Chairman Outlines Group's Agenda
The Advanced Medical Technology Association (AdvaMed) recently named its new board chairman—Zimmer Holdings Inc. CEO David Dvorak.
Dvorak is no stranger to the Washington, D.C.-based industry trade group. He has served AdvaMed in various capacities during the past 10 years. He has been an active member of the board since 2006 and has served as the chair of the association’s orthopedics sector since 2004. For the past two years he chaired AdvaMed’s Payment & Health Care Delivery Committee, where he led the group’s efforts to ensure that new payment delivery programs such as accountable care organizations and bundling systems support medical innovation and preserve patient/physician choice.
During a mid-April conference call, Dvorak gave a rundown of his vision for the association for the next three years, highlighting the importance of:
Dvorak said it was particularly important to “move beyond the beltway (Washington, D.C.) and listen to patients to better understand what they need.”
When asked, Dvorak clarified that these goals are extensions of what already is in place within AdvaMed, rather than brand new initiatives. He also said that any new in-house research will be made as public as possible in the interest of transparency.
Dvorak expressed a sense of unity with the global medtech industry. “All governments are facing the same problems,” he said. “Aging populations, chronic disease, economic issues. I see the medical technology industry as a solution, as it promotes public health.”
Medtronic Spinal Introduces New Surgical System
Medtronic Inc. has launched a series of electronic instruments for instrumented or reconstructive spine surgery. The Powerease system is compatible with two Medtronic pedicle screws already on the market—the CD Horizon Solera spinal system and the TSRH 3Dx spinal system. Pedicle screws usually are implanted into the vertebral pedicle to provide anchor points for rods in spinal fusion surgery. Powerease also is integrated with Medtronic products Nim-Eclipse neuromonitoring, O-Arm imaging, and Stealthstation navigation systems, giving spinal surgery with Powerease the ability to be more precise.
Powerease is used to drill, tap and drive specialized surgical spinal implants for both open and minimally invasive surgery. Medtronic executives are confident the system will be beneficial to both patients and surgeons.
“Biomechanical testing demonstrated that when compared with traditional instruments used for delivering spinal therapy, the Powerease system reduces surgeon’s fatigue associated with repetitive hand motion and enhances surgeon control, including in complex reconstructions of the spine,” Doug King, senior vice president and president of Medtronic Spinal, said in a news release. Risks associated with the system include breakage, slippage, misuse, or mishandling of instruments, which may cause injury to the patient or operative personnel.
The Powerease system demonstrated 51 percent less time required for tapping the pedicle and 55 percent less time required for placing pedicle screws during testing. This testing also showed greater control with 38 percent less wobble compared to manual instruments. Biomechanical testing, however, is not necessarily indicative of human clinical outcome.
Medtronic Spinal, which is based in Memphis, Tenn., provides a range of products and technologies for the treatment of spinal conditions.
Headquartered in Durham, N.C., Bioventus was born out of Smith & Nephew’s former Biologics and Clinical Therapies division, which was formed in 2008 and currently generates about $240 million in revenue worldwide. The spin-off was a “win-win” for employees and shareholders, Bioventus CEO Mark Augusti told Orthopedic Design & Technology.
“If you look at the state of strategy at Smith & Nephew—a global, multinational corporation—it’s trying to focus on growth markets outside the U.S. for its core products. On top of that it’s trying to reinvest into its core areas, which are surgical and implants, both in the wound management area as well as the orthopedic and sports medicine spaces,” he said. “So when you think about the investment dollars that they need, it’s hard to get down and appropriately scale your investments into biologics or active orthopedic healing, like Smith & Nephew would like to. So because they like the space and think it’s important, they found a really great partner that would help invest in that space.”
Bioventus has nearly 500 employees in the United States, mostly people who worked at Smith &
Nephew’s Biologics division, and currently has several products in its portfolio designed to help accelerate bone healing and treat osteoarthritis pain. Any employees from the division outside the United States will remain with Smith & Nephew until the global business is transferred over to Bioventus, which will happen over time as legal and regulatory approvals are obtained.
“Outside the U.S., because of the labor regulations, work councils and a variety of regulations throughout the different countries, we couldn’t do everything all at once,” Augusti said. “So we have secured the assets outside the U.S., and we’ve appointed Smith & Nephew as our distributor. All the people and all the countries that are still selling our products are now just doing it technically as our
distributor, and then over time we’ll work with Smith & Nephew to appropriately transition each country out, and work with the local authorities and local labor groups to make sure we do it in the proper way.”
The transaction has been finalized in the United States.
“Smith & Nephew is providing some transition services support, but we are operating as an independent entity,” Augusti said of the new company’s U.S. operations.
Augusti is a Smith & Nephew veteran, having worked there for seven years. He joined the company in 2005 as general manager of the Trauma division, and in 2006 took the position of president of Biologics & Spine, Orthopaedic Trauma and Clinical Therapies division (the same unit that is now Bioventus). Smith & Nephew has handed over the reigns to someone with experience and a proven track record not only with the company, but also in the business of active orthopedic healing.
What exactly is “active orthopedic healing?” Augusti explains that it’s not a new field but a new way of describing an existing field.
“It’s referred to as orthobiologics, but we call it active healing because studies show we have a mechanism that has a sociological effect in how it stimulates bone healing,” he said. “We want to look at other technologies that will assist the body’s natural healing and regenerative capabilities. Some people talk about regenerative medicine. We just try to brand it a little differently. We like to look at technologies and products that can be delivered locally [to the affected site in the body], whether inpatient or outpatient, and that will help the healing process.”
This “mechanism” Augusti referred to is called Exogen, a system that uses ultrasound signals to accelerate bone healing. It is the only U.S. Food and Drug Administration (FDA)-approved device on the market that uses a low intensity pulsed ultrasound signal for bone healing. It is used for non-union fractures—those that have not healed properly, and certain kinds of stress fractures. A number of clinical studies have shown that Exogen can accelerate the healing of indicated fresh fractures by 38 percent, can heal cortical bone in tibia 58 days faster, and can mend cancellous bone in distal radius 37 days faster. This system currently is Bioventus’ flagship product, but there are others in the portfolio and coming down the pipeline in the future.
Bioventus has some combination products that use joint fluid therapy to treat mild to moderate osteoarthritis pain in patients who do not respond to steroids or analgesics, are younger, or whose injury is not as far along.
“We have the Durolane products outside the U.S., which is a single injection technology,” said Augusti.
“And inside the U.S. we have the Supartz product which is a three- to five-injection regimen. We are pursuing Durolane approval in the U.S., where we’ll be running a clinical trial. We also have a broad, all-joints label in Europe. We’ll be running some small confirmatory trials in Europe over the next couple of years. We’re going to be active with the Exogen technology as well as with our partners on our joint fluid technology. But then, of course, we’ll be looking for other products and technologies that we think can fit into this space, and can help with pain patients.”
Bioventus hopes to have its global business fully transitioned from Smith & Nephew by the end of 2012, but Augusti believes it realistically will be finalized in the first quarter of 2013. Of course, with 2013 comes a whole new ball game if the proposed medical device excise tax is implemented. No device companies want to see this tax materialize, but in the event that it does, it is important to have a game plan.
The Advanced Medical Technology
Association, the Medical Device Manufacturers Association and other stakeholders have pointed to the loss of American jobs, harm to U.S. competitiveness, and stifling of innovation as some of the most detrimental effects of the tax.
“I think they make a very precise argument about the detrimental effects the tax will have on investments in the industry, and really good high-paying jobs,” Augusti noted. “Frankly, there’s a lot of innovation here at home, so I think the tax will have an unfortunate effect on an industry that has been pretty good for domestic business. For us, it’s going to mean we will have to make some tough choices on what we can afford to do in R&D, and what we can afford to invest in the company for our growth areas. We will look at sales outside the U.S. and sales inside the U.S., and think about what makes sense. I think it’s pretty self-explanatory—unfortunately there’s no free lunch, people still want a return on their investment. People still like proper investment positions.”
All in all, Bioventus is gearing up for the device tax just like most other medtech companies: preparing for the worst, but hoping for the best.
The company has a team that should help lead it into a successful future. Nearly all managers have come over from Smith & Nephew to continue in their roles at Bioventus: Alan Donze, vice president (VP) of commercial operations in the Americas; Duncan Fatkin, VP of global marketing and reimbursement; Peter Henderson, VP of compliance; Anthony James, VP of operations and quality; Walter Kwiatek, chief information officer; Leigh Ann Stradford, VP of human resources; and Henry Tung, VP of strategic planning and business development. Among the team, they share experience not only from Smith & Nephew but also from Stryker Corp., Baxter, Pfizer Inc., Boston Scientific Corp., and other medtech powerhouses. Bioventus also has hired Jeanne Forneris from American Medical Systems Inc. and Medtronic Inc. to serve as VP and general counsel.
Bioventus currently is located at the same address in the same building that housed the former Smith & Nephew Biologics division in Durham. The company will continue to maintain a close relationship with Smith & Nephew, which will retain 49 percent ownership of Bioventus. Essex Woodlands and its equity partners Pantheon Ventures LLP, Spindletop Healthcare Capital, Alta Capital Partners, Ampersand Capital Partners, and White Pine Medical, own 51 percent of Bioventus with their investment of $118 million.
European Regulators Clear JNJ Acquisition of Synthes
It worked. After unloading its DePuy Orthopaedics Inc. trauma division to make way for Synthes Inc., Johnson & Johnson (JNJ) has won the approval of European antitrust authorities to go through with the acquisition. DePuy is being acquired by Warsaw, Ind.-headquartered Biomet Inc. JNJ announced its intent to buy Switzerland-based orthopedic device company Synthes nearly a year ago, but European regulators feared the move would give JNJ a virtual monopoly in the orthopedics sector. JNJ wanted to fold Synthes into DePuy Orthopaedics to create, according to the company, possibly the world’s largest orthopedics business.
“The proposed acquisition would remove a competitor from some markets which are already concentrated,” Joaquin Almunia, the antitrust chief in the European Union (EU), said in a prepared statement last fall when regulators began their investigation of the proposed merger. “The commission needs to make sure that effective competition is preserved in order to maintain innovation and prevent harm to patients.”
Facing such scrutiny from the European regulators, JNJ decided to sell its DePuy unit, a compromise that has proven successful.
According to a statement released April 19 by the commission, its concerns were based on “very high combined market shares of the merging entities in these markets, the rather mature character of the products, and the strong position of the AO Foundation, a highly reputed Swiss-based surgeon-led organization with an exclusive relationship with Synthes.”
Though it has been approved, the acquisition still may prove troublesome for JNJ. Synthes has had its fair share of legal trouble—in 2009, the company settled charges with New Jersey prosecutors that its clinical investigators did not disclose their financial interests; and late last year, Synthes sued several former employees and their hiring companies, claiming raids on staff, breaches of confidentiality agreements, and violations of patents. In March, the company and four former executives were sued in California by the families of two patients who died on the operating table allegedly from the misuse of bone cement the company had developed. Several executives who admitted their involvement in an illegal clinical trial of the bone cement have been sent to jail.
DePuy has had its share of troubles as well. The company has been fighting criticism due to the 2010 recall of its metal-on-metal hip implants. The devices gained a lot of attention for leaving metal debris in the implant area. There still are patients currently using the device, and David Floyd, DePuy president at the time of the recall, acknowledged that such use would be a concern.
Now that the acquisition deal has materialized, Synthes’ baggage is now JNJ’s. The healthcare conglomerate, however, hopes to gain a stronghold in the trauma sector that it didn’t have before, so the payoff could be worth it.
“We are pleased that the European Commission has granted conditional clearance of Johnson & Johnson’s acquisition of Synthes,” JNJ spokeswoman Lorie Gawreluk said. “We expect to fulfill our commitment to the Commission with the divestiture of the DePuy Orthopaedics Trauma business to Biomet in the second quarter of 2012.”
The outside date is set at June 25.
The Biomet acquisition of DePuy is valued at $280 million, while Synthes will be sold to JNJ for $21.3 billion.
Water Street to Acquire Orthofix’s Sports Medicine Business
Orthofix International N.V. and Breg Inc. are parting ways.
The orthopedic device manufacturer is selling Breg, its sports medicine business unit, for $157.5 million in cash to Chicago, Ill.-based private equity firm Water Street Healthcare Partners LLC.
Executives expect the sale to be completed in the second fiscal quarter of 2012.
Orthofix will use the $140 million in net proceeds from the sale to pay off debt.
Orthofix, headquartered in Curacao, Netherlands Antilles, acquired California-based Breg in 2003. Breg features a portfolio of bracing and cold therapy products that treat various sports-related conditions.
In an April 24 conference call, Orthofix CEO and President Robert Vaters discussed the reason the company decided to sell Breg.
“It allows us to execute on our strategic focus to develop and deliver innovative repair and regenerative solutions to the spine and orthopedic markets,” he said. “Specifically, our de-leveraging gives us more capacity to invest in the repair and regeneration value proposition and at the same time to deliver gross and operating margin improvement...”
Water Street partner Chris Sweeney said the firm would “leverage [the] team’s deep medical products knowledge, extensive operating experience and network of relationships to strategically expand Breg’s innovative products and global presence.”
Upon the sale’s closing, Orthofix will file the required documents with the Securities and Exchange Commission, including any impact of pre-closing liabilities the company will retain.
Founded in 1980, Orthofix develops trauma and spinal fusion products. Its North American headquarters is located in Lewisville, Texas. Water Street invests in companies focused in medical and diagnostic products, specialty distribution, outsourced healthcare services, and specialty pharmaceutical products and services.
New AdvaMed Chairman Outlines Group's Agenda
The Advanced Medical Technology Association (AdvaMed) recently named its new board chairman—Zimmer Holdings Inc. CEO David Dvorak.
Dvorak is no stranger to the Washington, D.C.-based industry trade group. He has served AdvaMed in various capacities during the past 10 years. He has been an active member of the board since 2006 and has served as the chair of the association’s orthopedics sector since 2004. For the past two years he chaired AdvaMed’s Payment & Health Care Delivery Committee, where he led the group’s efforts to ensure that new payment delivery programs such as accountable care organizations and bundling systems support medical innovation and preserve patient/physician choice.
During a mid-April conference call, Dvorak gave a rundown of his vision for the association for the next three years, highlighting the importance of:
- Preserving patient access to innovative medical technology;
- Working with the U.S. Food and Drug Administration to improve efficiency; and
- Repealing the current U.S. government’s medical device excise tax.
- Increase operational presence in international markets, particularly in India and China;
- Increase in-house research so AdvaMed can compile data-driven analysis of market and industry behavior; and
- Listen to patients to learn their needs.
Dvorak said it was particularly important to “move beyond the beltway (Washington, D.C.) and listen to patients to better understand what they need.”
When asked, Dvorak clarified that these goals are extensions of what already is in place within AdvaMed, rather than brand new initiatives. He also said that any new in-house research will be made as public as possible in the interest of transparency.
Dvorak expressed a sense of unity with the global medtech industry. “All governments are facing the same problems,” he said. “Aging populations, chronic disease, economic issues. I see the medical technology industry as a solution, as it promotes public health.”
Medtronic Spinal Introduces New Surgical System
Medtronic Inc. has launched a series of electronic instruments for instrumented or reconstructive spine surgery. The Powerease system is compatible with two Medtronic pedicle screws already on the market—the CD Horizon Solera spinal system and the TSRH 3Dx spinal system. Pedicle screws usually are implanted into the vertebral pedicle to provide anchor points for rods in spinal fusion surgery. Powerease also is integrated with Medtronic products Nim-Eclipse neuromonitoring, O-Arm imaging, and Stealthstation navigation systems, giving spinal surgery with Powerease the ability to be more precise.
Powerease is used to drill, tap and drive specialized surgical spinal implants for both open and minimally invasive surgery. Medtronic executives are confident the system will be beneficial to both patients and surgeons.
“Biomechanical testing demonstrated that when compared with traditional instruments used for delivering spinal therapy, the Powerease system reduces surgeon’s fatigue associated with repetitive hand motion and enhances surgeon control, including in complex reconstructions of the spine,” Doug King, senior vice president and president of Medtronic Spinal, said in a news release. Risks associated with the system include breakage, slippage, misuse, or mishandling of instruments, which may cause injury to the patient or operative personnel.
The Powerease system demonstrated 51 percent less time required for tapping the pedicle and 55 percent less time required for placing pedicle screws during testing. This testing also showed greater control with 38 percent less wobble compared to manual instruments. Biomechanical testing, however, is not necessarily indicative of human clinical outcome.
Medtronic Spinal, which is based in Memphis, Tenn., provides a range of products and technologies for the treatment of spinal conditions.
