05.19.10
Lawmaker goes after device tax; Flexuspine clinical trial OK’d by FDA; Watch out for Chinese titanium.
A 30-year knee replacement? Longer-lasting implants are one of the primary goals of artificial joint manufacturers. With its recent 510(k) clearance, Smith & Nephew is, in theory at least, a little closer to that objective.The company received 510(k) clearance from the U.S. Food & Drug Administration to label its Legion knee implant as good for 30 years of use. Smith & Nephew’s orthopedic division ran tests simulating 30 years of physical activity on the implant, which includes the firm’s Verilast technology.
The clearance was based on the agency’s findings that the implant would “provide wear performance sufficient for 30 years of actual use under typical conditions.” Most knee implants are expected to last 10 to 15 years. The key words are “under typical conditions.” Numerous other factors, such as infection, can shorten the life of an implant. According to the company, Verilast technology produced an 81 percent reduction in wear, which is the leading cause of knee replacement failure. When knee implants fail, patients most often require revision surgery to replace the original implant, increasing the risk of infection and bone loss.
“Physically active patients want to end their knee pain for good,” said Joe DeVivo, president of the firm’s Memphis, Tenn.-based orthopedic division. “We’re working to make knee implants that last a lifetime—that’s our goal, and we’ve validated Verilast technology out to 30 years for a market that views 10 to 15 years as the gold standard. This is not an incremental improvement; it’s a generational leap forward for active patients.”
Verilast technology is a combination of the company’s Oxinium material and highly cross-linked polyethylene. According to company officials, the pairing yields “virtually indiscernible wear.” Oxinium is used on the femoral side of the joint, and the polyethylene is implanted on the tibial side. The company performed wear simulator testing of the knee replacements during three continuous years. Oxinium oxidized zirconium is a proprietary material that, according to the company, has been used in more than 200,000 knee procedures. Smith & Nephew officials claim it also is the only hypoallergenic metal-bearing surface since it contains no detectable amounts of nickel, the element commonly associated with metal allergies.
“If we’re successful in our drive to make knee replacements that last a lifetime, that could mean significant cost savings to the healthcare system,” DeVivo added. “And patients may avoid the pain and the downtime associated with revision surgery.”
New PMA Advisory Panel Procedures Enacted by FDA
The U.S. Food and Drug Administration (FDA) has changed its medical device premarket review process. According to officials in the FDA’s Center for Devices and Radiological Health (CDRH), the move follows a growing number of medical device advisory panel meetings in the past several years.
In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to CDRH officials. The FDA hoped that the changes, which went into effect on May 1, allow review panels to use their time more effectively. Under the new system, the panel no longer will vote on a device’s approvability or conditions of approval but rather on the safety and effectiveness of a device and its risk versus its benefit. The change is aimed at allowing panel members to address areas of scientific expertise, rather than regulatory issues with which they might not be familiar.
The mode of the deliberation is new as well. Panelists will be instructed to present their scientific opinions and recommendations without interruption during an hour-long deliberation, during which the panel may ask questions of both the medical device firm’s representatives and the FDA.
“We believe focusing the amount of time the sponsor may respond to questions to the panel will allow for a more robust discussion among the experts and provide CDRH with information needed to reach a decision regarding the issue before the panel,” according to CDRH officials.
The method of voting also changed. Experts now will vote using an electronic ballot instead of raising their hands simultaneously, according to the FDA statement.
“The ballot process allows each panel member to cast their vote without immediate influence by other votes,” according to a statement released by the agency.
In addition, unlike in the past when CDRH reviewers presented a unified, consensus analysis of supporting data, they now will present that data and analysis in addition to the range of scientific opinion of group members. This move will allow more in-depth discussion on safety and effectiveness and risk versus benefit of the device under consideration, officials said.
“By taking a broader view of the data that is supplied and the opinions of different reviewers and offices within CDRH, we will provide the panel the ability to have a more in-depth discussion on safety and effectiveness and risk versus benefit of the device at issue,” CDRH Director Jeffrey Shuren said in a statement.
The FDA and CDRH will continue to evaluate panel procedures and make changes when necessary. In addition to these specific changes to the advisory committee procedures, the FDA also issued draft guidance for disclosing and minimizing financial conflicts for advisory committee members.
Lawmaker Proposes Repealing Device Tax
Rep. Erik Paulsen (R-Minn.) has introduced the Defend Medical Innovation Act, legislation that immediately would repeal the 2.3 percent excise tax included in healthcare reform, which would take effect in 2013.
“The medical technology industry is an American success story, responsible for life-saving technologies and tens of thousands of jobs in Minnesota alone,” said Paulsen, who is co-chairman of the U.S. House of Representatives’ Medical Technology Caucus. “Once it takes effect, this tax will harm job growth, slow innovation and raise costs. The right thing to do is stop this tax now, before its negative impact takes hold.”
In a statement, Paulsen stressed the importance of keeping the medical device industry in the United States healthy and competitive, noting that U.S. medical firms employ more than 350,000 people. In addition, the average salary for workers in this sector is $70,000, or 49 percent more than the average private sector job, and 18 percent more than the average manufacturing job.
While a total repeal of the tax would be a significant load off the industry’s back, many see a complete reversal of the tax unlikely.In the meantime, industry advocacy groups have indicated that a “carve out” to the tax could be a more realistic possibility.Aside from the bottom-line burden the tax imposes on device firms, critics argue that the law doesn’t distinguish between the percentage of tax paid by small and large firms—and that this tax is particularly burdensome on small and midsize medtech companies. Industry insiders say that innovation would be stymied significantly by the law—especially because most of the innovation comes from small, cutting edge firms with fewer than 50 employees.
For example, legislation to amend the currently approved version could exempt the first $150 million of a company’s revenue from the new tax, giving nascent companies the chance to grow their business before being hit. A graduated scale would kick in as company revenues increased. That would be similar to a tax structure in place now for pharmaceutical firms.
Such a system was included in previous versions of proposed healthcare reform legislation, but was not included in the current law.
According to the Washington, D.C.-based Advanced Medical Technology Association (AdvaMed), there are more than 6,000 medical device companies in the United States and fewer than 5 percent have annual sales of more than $100 million. According to AdvaMed officials, the tax impacts smaller companies especially hard, since some have no profits and almost all rely entirely on domestic sales for their revenues (the excise tax is levied against domestic sales only).
FDA Gives OK for Flexuspine Clinical Study
The U.S. Food and Drug Administration (FDA) has granted conditional approval to Flexuspine Inc. to begin the first phase of a clinical study for a total spine arthroplasty system. This is the first study of its kind in the United States, according to the Pittsburgh, Pa.-headquartered firm.
Flexuspine’s FSU Total Spinal Segment Replacement is designed to provide an alternative to fusion by re-establishing mobility in an affected segment of the lumbar spine, according to the company. The device is composed of an interbody disc component and posterior dynamic resistance component and is designed as a system to restore the motion and natural kinematics of the affected spine segment.
The approval process included an extensive review of Flexuspine's research, design and biomechanical testing of the FSU device by the FDA, as well as an assessment of Louis Nel Jr., M.D.’s, first-in-man clinical series performed in South Africa.
“This is a much needed next step in spinal arthroplasty. The potential advantages of this technology could make it the first real ‘total’ level replacement,” said Nel.
Erik Wagner, chief technical officer, said: “The FSU is not like the currently approved disc or facet replacement devices on the market today that only partially rebuild the motion segment. The FSU has three separate parts working together, similar to healthy discs and facets, and is designed to achieve segmental reconstruction from a single posterior approach.”
Flexuspine plans to begin patient enrollment in the U.S. feasibility study soon while continuing to establish similar clinical study sites in several countries outside the United States, according to company officials.
Continued Vigilance Needed for Chinese Titanium, CDRH Officials Say
U.S. Food and Drug Administration (FDA) officials are encouraging device manufacturers to continue monitoring titanium alloy imported from China for a potential defect.
There have been no injuries or device failures linked to the defect since it first surfaced late last summer, but medical device manufacturers nonetheless should remain vigilant in their supplier controls, officials with the FDA’s Center for Devices and Radiological Health (CDRH) claim. CDRH administrators are advising companies to determine the impact of the material specification problem and take appropriate corrective actions such as recalls.
Authorities traced the defective titanium to a manufacturing plant in China. Though it met industry standards established by ASTM International (a standards organization based in West Conshohocken, Pa.), the titanium contained a defect known as alloy segregation, meaning the metals were not melded homogenously. Such an improper melding process could possibly cause the metals to remain unmixed.
The defective raw material made its way from China to distributors, and eventually to at least 130 manufacturers that used the titanium in products (predominantly orthopedic goods), said Timothy A. Ulatowski, director of the Office of Compliance within the CDRH. Over the last several decades, titanium has become a standard material for medical devices such as hip and knee joints, bone screws and plates, dental implants, surgical devices, pacemaker cases and centrifuges due to its high strength and biocompatibility, low modulus and its compatibility with both magnetic resonance imaging (MRI) and computed tomography (CT) procedures.
One of the suppliers of the tainted titanium was G&S Titanium Inc., a Wooster, Ohio-based bar, coil and wire mill. G&S CEO Roger Geiser said his company received the raw material from Dalian Sunny Titanium Industry Ltd., a seven-year-old Chinese firm co-owned by Hong Ji Material Limited Company and the Research Institute of Chinese Academy of Science. G&S Titanium, however, stopped purchasing titanium from Dalian after the problem was first reported by an unnamed device manufacturer.
That manufacturer, according to published reports, was unable to process titanium through a machine used to make its product (the specific device was never identified). The FDA learned of the problem after the manufacturer approached its supplier, G&S, which in turn, notified Dalian of the defect. The FDA visited G&S’ facility, but details about that inspection were not released.
Officials from the FDA and the Orthopedic Surgical Manufacturer’s Association have been working with affected device firms to address the issue, but it has not been an easy task. For starters, only a destructive test could possibly identify the defect, and such a test would weaken the titanium, industry experts noted. In addition, the defect could be so localized that only a small piece of one device actually could be defective.
G&S tested the titanium it received from Dalian and found it to be within industry standards for strength and chemistry specifications.
First Commercial Implant of Renew Spinal Device
Interventional Spine, Inc. recentlymarked the first commercial implant of its Renew interspinous allograft technologyin the United States.
The Renew implant is an interspinous process device made from allograft for the treatment of lumbar spinal stenosis. The device was designed for ease of implant, Interventional Spine executives said, in addition to providing a more “natural” interference within the spinous process.
The Renew implant is available in six different sizes to accommodatepatient anatomy. Company officials estimate that the market for the device exceeds $400 million in the United States and plans a limited product launch of the product in June, with a full U.S. launch by the end of the year. The firm predicts that the Renew Implant will be a major contributor to revenue growth in 2011 and 2012.
The first implant was performed at the Inova Fairfax Hospital in Fairfax, Va., by Ronald C. Childs, M.D.
“I am very pleased with this product,” Childs said following the procedure. “The use of the Renew Implant provides, in my view, a welcomed alternative to the other various interspinous process devices made from synthetic materials presently in the market.”
Interventional Spine, Inc. is a privately held company based in Irvine, Calif., that designs implantable devices for the spine that can be deployed via percutaneous techniques.
Ascension Orthopedics Rolls Out NuGrip Implant for the CMC Joint
Ascension Orthopedics, Inc., recently released its NuGrip implant. The joint replacement is designed to relieve pain and restore range of motion in the first carpometacarpal (CMC) joint—the base of the thumb.
The implant is made of pyrolytic carbon, also called pyrocarbon, a material known for its superior wear and biocompatibility characteristics. Company officials say the material is a “bone-preserving, reliable” alternative to soft tissue reconstruction, which is the current standard of care.
“The NuGrip implant is a great option for patients with osteoarthritis who are in pain and would like to maintain function,” said Lorenzo Pacelli, M.D., a physician with the Scripps Clinic Torrey Pines in La Jolla, Calif. “My patients have experienced pain relief and have been able to return to normal daily life activities with the NuGrip.”
The implant is designed as a single component that minimizes bone resections and preserves the trapezium bone in the wrist. The stem is anatomically designed for a press fit within the intramedullary canal without cement. The specifically designed stem and collar enhance stability and maintain the anatomy’s joint space, officials said. The spherical head has an extended circumference, which designers claim provides maximum opportunity for range of motion within the trapezium. The device offers eight sizing options to fit patient anatomy.
“Ascension has established itself as a market leader in innovative products with proven clinical success,” said Guy Mayer, CEO of Ascension Orthopedics. “We are committed to remaining at the forefront of orthopedic advancements capitalizing on our pyrocarbon technology. The NuGrip is a great addition to our product offerings designed to meet the needs of patients suffering from arthritis of the hand.”
Ascension Orthopedics was founded in Austin, Texas, in 1996.