FDA Panel Has No Answer for Metal-on-Metal Implant Problem

Metal-on-metal (MoM) hip implants have been under the microscope since 2010, when studies—including one that appeared on the online version of The Journal of Bone and Joint Surgery—indicated problems with cobalt toxicity. All-metal hip implants are commonly constructed of cobalt-chromium alloy. Around the same time, The Journal of Arthroplasty warned doctors to use the MoM devices only with “great caution, if at all.” Those most likely to suffer negative reactions to MoM implants are women and overweight patients.

In early 2010, The New York Times started reporting the reluctance of many orthopedic surgeons to perform MoM hip implants amid concerns of severe tissue and bone damage in some patients. There were rumblings in the orthopedic medical community before 2010 of the tendency of MoM hip implants to wear down quickly, depositing large amounts of metal debris in the body, leading to toxicity.

Concern has continued to rise. In February, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency published a Medical Device Alert, advising that patients with MoM hip implants sized 36 mm or larger follow more aggressive follow-up schedules. In the United Kingdom, regulators advise patients with MoM implants to get yearly blood tests whether they are experiencing adverse symptoms or not.

There have been two major MoM total hip replacement device recalls in the United States. Zimmer Holdings voluntarily recalled its Durom Acetabular Component in 2008 due to inadequate directions on its labels. Then in 2010, Johnson and Johnson subsidiary DePuy Orthopaedics Inc. recalled its ASR total hip systems due to a high number of revision rates from registries outside the United States.
The Durom now is available with more detailed surgical technique instructions and a surgeon training program, but the ASR never returned to the market.

On June 28, the U.S. Food and Drug Administration (FDA) concluded a two-day expert advisory panel meeting evaluating the safety of MoM implants. The 18-person panel discussed current knowledge about the safety and effectiveness of MoM hip arthroplasty systems. According to the FDA, the group was convened to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.

The American Academy of Orthopaedic Surgeons had representatives on the panel, as did the medical device manufacturing industry (Biomet’s Robert E. Durgin, J.D.) and consumers (Connie Whittington, M.S.N., R.N., of Peachtree Orthopaedic Clinic). Barbara Berney served as the patient representative.

Despite the two 12-hour sessions, however, no conclusive advisories have yet been issued.

Presented with a plethora of information, panel member Scott Evans, Ph.D., had this to say: “the issue is that it’s from observational studies and registries that are not optimally designed to answer the very, very difficult questions we’ve been trying to hassle with today.” Evans is a Harvard University biostatistician.

Meeting Chair William Rohr, M.D., of Mendocino Coast District Hospital, said, “I do not use metal-on-metal hips, and I can see no reason to do so.”

Polymer and ceramic are the long-used traditional materials for hip implants. The reason surgeons moved to metal was because of the suggestion that they would be more durable. Their hardness has backfired, however, as they cause tissue damage for the very same reason some medical practitioners were attracted to them in the first place.

“No single bearing surface meets the needs of all patients,” said Paul Voorhors of DePuy Orthopaedics. “Not all metal-on-metal products are the same, and each should be evaluated on its own merits.”

“Metal-on-metal, ceramic-on-ceramic and metal-on-ceramic are unforgiving couples,” said panel member Michael B. Mayor, M.D., of Dartmouth Medical School’s Thayer School of Engineering. “They all show evidence of impact loads delivered by the edge of the acetabular component onto the surface of the head in the form of edge stops and gouges. Those are fairly severe alterations of articular surface.”

On the final day of the sessions, panel experts said that patients with MoM implants complaining of pain should get regular X-rays and blood tests for metal levels. However, as the panel acknowledged, there are problems with blood test accuracy and interpretation of the results. Currently, there are no standard tests for chromium.

In his concluding remarks, Rohr tried to consolidate the overall opinion of the panel. He recommended that the FDA look into additional labeling regarding the technical difficulty of implantation, as well as warnings to patients that both pseudo-tumors and elevated metal ion levels have been reported in both symptomatic and asymptomatic patients.

These recommendations are still less aggressive than many that already are in place overseas. The FDA has not yet implemented or endorsed any of these recommendations, suggesting that the administration may need to parse through the information and opinions presented by professionals on the panel.

Stryker Solidifies Plans for Layoffs
Joining Zimmer Holdings Inc., Kalamazoo, Mich.-based Stryker Corp. now is carrying out its promise of layoffs in preparation for the seemingly inevitable device tax set to begin in January 2013. The company is eliminating 107 positions and closing two New York manufacturing facilities.

The plants, which are used by Stryker subsidiary Gaymar Industries Inc., will be closed by the end of the year. According to the Worker Adjustment and Retraining Notification notice filed by the company with the U.S. Department of Labor, 11 workers will be affected at the West Seneca plant and 96 at the Orchard Park facility. The layoffs will begin Sept. 21 on a rolling basis, and both plants will close for good on Dec. 31.

Stryker bought medical manufacturer Gaymar Industries in late summer 2010 for $150 million in cash, before which the supplier had a 10-year strong relationship with the orthopedic device company. It’s bitter news that the shuttering of the Orchard Park and West Seneca plants comes so soon after the acquisition deal.

The orthopedic device behemoth first announced plans for layoffs in November 2011, and at the time articulated the intention to reduce costs by $100 million in order to offset the cost of paying the upcoming 2.3 percent medical device excise tax.

“Here we are, one of the greatest industries in the country, and we’re staring down on Jan. 1st, 2013, and the addition of a 2.3 percent excise tax, while on the other side all the discussion in Washington is about creating jobs,” former Stryker CEO Stephen MacMillan said in November.

The tax is expected to raise $29 billion over 10 years to help pay for the Affordable Care Act implemented by the current administration, and ruled constitutional by the U.S. Supreme Court in June this year. Federal lawmakers, urged on by industry players, are trying very hard to get the tax repealed before Jan. 1—but as evidenced preparations such as these by Stryker, medtech isn’t confident the repeal will happen. President Obama has promised to veto a repeal if it reaches his desk.

Gaymar Industries produces acute care technology for patient temperature and pressure ulcer management. In 1977, the company established Medisearch PR Inc. in Puerto Rico to supplement the New York operations. That facility will remain open and functional.

Integra Lifesciences Introduces Joint Fusion System
Integra Lifesciences Holdings Corp. has released its IPP-ON PIP Fusion System for fixation of proximal interphalangeal (PIP) joint arthrodesis. Arthrodesis, also known as artificial ankylosis or syndesis, is the artificial induction of joint ossification, or laying down new bone material, between two bones via surgery. The system is indicated for use in the lesser toes for rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and second toe shortening. The U.S. Food and Drug Administration has granted the device 510(k) clearance.

Hammertoe is a deformity that occurs when there is a shortening of the tendon that controls toe movement. The shortened tendon causes the middle joint of the toe to be bent upward and the most distal joint downward.

“Integra IPP-ON PIP Fusion System offers surgeons a straightforward, one-piece alternative to hammertoe fixation,” said Bill Weber, vice president and general manager of Integra Extremity Reconstruction. “Unlike some similar products, our device is not temperature sensitive and has no handling or storage requirements. This is an excellent feature, since it is ready for use whenever the surgeon needs it. This system is a valuable addition to our already extensive portfolio of forefoot extremity products.”

The system is constructed as one stainless steel interphalangeal fusion device that is available in two sizes to accommodate varying patient anatomy. The device is being touted by the company as anatomically adaptive by offering both cortical bone (or compact bone) and cancellous bone fixation.
The Integra IPP-ON PIP Fusion System is distributed through Integra’s Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair. The company is headquartered in Plainsboro, N.J.

Benvenue Snags $25 Million in Series D Funding
Benvenue Medical has received $25 million in Series D funding from existing investors DeNovo Ventures, Domain Associates, Technology Partners and Versant Ventures. Benvenue intends to use the funds to support its three minimally invasive products that treat degenerative disc disease with spinal fusion and vertebral compression fractures (VCFs) on the global market. The funds additionally will be used to bring those products to the U.S. market.

“Our investors share our excitement about our rapid growth and positive momentum, and we’re gratified by their continued support for our vision and progress,” said Robert Weigle, Benvenue CEO.
The investors, for their part, expressed confidence in the team at Benvenue. Nimesh Shag, principal at Domain Associates, called the company “innovative” and praised its “top-notch team” in a statement.
The three products Benvenue will be carrying with this money are:

• The Kiva VCF Treatment System, which currently is commercially available in Europe. According to the company, the Kiva has been used to treat 800 VCFs globally. In Europe, the device is distributed by Zimmer Spine. Kiva is undergoing a clinical trial to support 510(k) market clearance from the U.S. Food and Drug Administration (FDA);
• The Blazer Vertebral Augmentation System, also used to treat VCFs. It is the first of Benvenue’s clinical products to be commercially available in the United States; and
• The Medical Luna Interbody Spacer System for spinal fusion procedures. Benvenue is enrolling patients for a European post-market study, after which the device will be available in the European Union. The company intends to submit a 510(k) application to the FDA later this year.
• Benvenue Medical is based in Santa Clara, Calif. The company primarily is focused on spine repair devices.

Precision Spine Makes a Pair of Acquisitions
Precision Spine Inc., based in Parsippany, N.J., has acquired Spinal USA LLC and Precision Medical of Mississippi LLC, both based in Pearl, Miss., for $72 million. According to a statement released by the company, Precision Spine will expand on the market growth the two companies already have achieved with the release of the Vault Stand Alone ALIF (anterior lumbar interbody fusion) System and the S-Lok PC Posterior Cervical System in 2011. Precision Spine promises several new products from the pipeline this year.

The Vault system is used with autogenous bone graft and indicated for intervertebral body spinal fusion in patients with degenerative disc disease up to Grade I spondylolisthesis (where a vertebra in the lower spine slips out of place). The S-Lok system fuses the cervical and thoracic spine, and is indicated for treatment of degenerative disc disease, spondylolisthesis, fracture and dislocation, revision of previous cervical spine surgery, and tumor procedures.

“Precision Spine is well positioned in this challenging economy to better address the needs of the aging population in a cost effective manner,” Precision Spine CEO James Pastena said, noting the orthopedic sector will experience significant growth due to aging populations. “Our subsidiaries have a proven track record of lowering manufacturing costs while delivering high quality medical products and reducing costs for local and national health care providers and their respective patients. These achievements have driven a growth rate of more than 30 percent in a market experiencing overall negative growth. We believe we can accelerate that rate, with several initiatives planned that will build on our strengths, expand our product lines and allow us to deliver even greater value to communities hard hit by the current economy.”

Gil Aust, M.D., former board chairman of Spinal USA and Precision Medical, highlighted the companies’ dedication to low-cost products. “We are proud to have built these companies for the benefit of patients who are struggling with the costs of healthcare and providers who are trying to deliver the best medical care for their patients at the greatest value proposition,” he said in prepared remarks. “Precision Spine recognizes our vision and shares our goals for giving back to the community.”

Aust also is a spinal surgeon at the Campbell Clinic in Memphis, Tenn.

NuVasive to Further Expand Memphis Facility
San Diego, Calif.-based spinal device developer NuVasive Inc. is spending $75 million to expand its distribution center in Memphis, Tenn. Only two years ago, the company spent $1.6 million to double the size of the 123,000-square-foot facility, which currently houses offices and a distribution operation.
Memphis is an important location for NuVasive due to its ideal location as a transportation hub.

Intersecting the city are the Mississippi River crossing for Interstate 40, which goes east-west across the country, and the north-south thoroughfare Interstate 55. In 2010, then-president and chief operating officer Keith Valentine pointed out the facility’s proximity to FedEx as a major advantage of the location: “That gives us greater access across the country.” Indeed, FedEx is located in Memphis for the same reason of easy access.

NuVasive is seeking a tax break to accomplish this expansion and add 17 jobs in Memphis. The Economic Development Growth Engine (EDGE) for Memphis and Shelby County, Tenn., considered NuVasive’s application for a PILOT (payment-in-lieu-of-taxes) at its June 20 board meeting.

NuVasive received a PILOT in 2006 when it first opened the 100,000-square-foot facility and employed 50 people. The latest new hires will earn an annual average of more than $49,000 and boost the total number of local employees to 163.

Hanger Changes Company Name
The company formerly known as Hanger Orthopedic Group Inc. has changed its name to Hanger Inc., according to an announcement made on June 8. The company’s New York Stock Exchange symbol HGR remains the same. The name change was approved by the company’s stockholders during their annual meeting in May.

Hanger President and CEO Vinit K. Asar cited the company’s expansion as the reason for this change:
“Hanger has grown and evolved over the years from solely an orthotic and prosthetic patient care company to one of the leading clinical authorities in the provision of integrated rehabilitative solutions with a full range of services and products. When you consider our continuing disciplined diversification strategy, our former company name was limiting. Having just celebrated our 150th anniversary, the timing is right to position the company for the future, while continuing to emphasize the innovative legacy of our namesake, Mr. James Edward Hanger, the first amputee of the American Civil War.”

The name change is one part of a larger initiative to rebrand and expand the company. In 2010, Hanger began a strategic branding effort that included partnering with external experts to conduct extensive research with nearly 1,000 internal and external stakeholders. Hanger conducted market and internal analyses, focus groups, surveys, and one-on-one interviews with patients and customers, referral sources, industry thought leaders, investors, payers, and competitors. Hanger’s core patient care business also has been renamed—formerly Hanger Prosthetics and Orthotics, it now simply is Hanger Clinic.

On Feb. 1, the company unveiled its extensive rebranding plan at the Annual Hanger Education Fair and National Meeting in Las Vegas, Nev. The plan includes not only new names, but also new logos, designs, and communications across Hanger’s various businesses and throughout Hanger Clinic’s more than 700 clinics nationwide.

Austin, Texas-based Hanger Inc. provides orthotic and prosthetic (O&P) patient care services, distributes O&P devices and components, and provides therapeutic solutions to the broader post-acute market. Hanger also provides neuromuscular technologies through its Innovative Neurotronics subsidiary, and provides specialized rehabilitation technologies as well as evidence-based clinical programs for post-acute rehabilitation centers through its Accelerated Care Plus subsidiary.