The Metal-on-Metal Debate Rolls On

Joshua J. Jacobs, M.D., cannot fully explain his aversion to metal-on-metal hip implants. More than a dozen years ago, well before problems with thesedevices began to surface, Jacobs favored

artificial joints made of metal and highly crosslinked polyethylene.

“At the time, the highly crosslinked polyethylene is where I thought the industry was going. It’s where my instincts led me,” Jacobs said during an expert roundtable discussion with journalists during this year’s American Academy of Orthopaedic Surgeons Annual Meeting in San Francisco, Calif. “I had no idea back then that I would someday be sitting in a room talking about what was going on with these implants. I had no idea that would happen.”

Neither did the creators of metal-on-metal hip replacements, which havebecome the proverbial black sheep ofimplant choices as controversy grows over their potential health hazards. The failure rates of metal-on-metal hips and concerns about the gradual buildup of wear particles in the body have prompted many patients to rethink their decision toundergo joint replacement surgery with all-metal implants. Such hesitancy has led to a sharp decline in the number of metal-on-metal joints used in replacementsurgeries; before they fell out of favor, all-metal implants accounted for nearly one-third of the estimated 250,000 hip replacements performed annually in the United States. About half a million

patients have received metal-on-metalreplacement hips, according to one estimate, though more precise figures are difficult to ascertain due to the lack of a national implant tracking system.

Though he prefers implants made from metal and highly crosslinked polyethylene, Jacobs was fair in his assessment of all-metal hip replacements, noting that most patients with the devices are satisfied with their choice. He also warned against classifying all metal-on-metal hip implants as “one group,” telling reporters that the joint replacements vary by size, design and specific features.

“It’s very perilous to talk about metal-on-metal implants as one group,” Jacobs told a dozen journalists at his roundtable discussion. “It’s a very heterogeneous group. If you bunch them all together, you miss the nuances…metal-on-metal [hip implants] can have large heads, they can have small heads, they can be designed for a hip resurfacing or they can be designed as a total replacement.”

And every design from orthopedic device companies has its own unique features, which can impact the way the product performs, Jacobs noted.

“In general, there are some devices that have performed very poorly and have been removed from the market. Others have done very well. Even with the worst designs, the majority of patients still have good results from their surgeries,” said Jacobs, who is incoming first vice president of the American Academy of Orthopaedic Surgeons and an adult reconstructive surgeon at Rush University Medical Center in Chicago, Ill. “The majority of patients with these [metal]implants are doing quite well, but the failure rates are very disappointing and as orthopedic surgeons we are not happy about those rates. When there is a failure from animplant, we feel it, the patient feels it and the system feels it.”

The healthcare system is about to feel it in a big way, too.

All-metal hips have been failing at surprisingly high rates in recent years, giving out within one or two years of the original procedure. Hip implants are designed to last 15 to 20 years but the wear of metal parts sometimes can generate debris that damages soft tissue and bone, crippling patients and forcing them to replace (or in certain cases, revise) the implants.

Implant durability can vary depending on the materials used. For example, highly crosslinked polyethylene is used lessfrequently for joint replacements but has been shown in a laboratory setting todecrease wear by about 94 percent, including a substantial reduction in pittingand delamination.

Ceramic-on-ceramic hip replacements produce fewer wear particles, but can produce an irritating squeaky noise during use. A fairly recent study (released last year) concluded that artificial hips and knees developed within the last five years are not significantly better than older devices; 30 percent, in fact, were considered worse than their earlier counterparts.

It is one of the older models that has become a source of controversy for the industry, though. Eighteen months ago, Johnson & Johnson’s DePuy Orthopaedics unit recalled its 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 in order to preserve more bone.

The company reportedly recalled both products due to the number of patients who needed a second hip replacement.

Many of those patients are now suing DePuy (some industry observers have estimated that as many as 3,500 patients have filed suit against the company). The lawsuits, in turn, have ignited a financial scramble as patients attempt to recover lost wages and pay off astronomical medical bills, insurers try to regain their expenses from settlements and Medicare fights for its fair share. Medical and legal experts estimate the hip failures may cost taxpayers, insurers, companies such as DePuy and others billions of dollars in coming years, contributing to the skyrocketing cost of healthcare. The financial fallout is expected to be unusually large and complex because the controversy over metal-on-metal hips involves a class of products rather than a single device or just one company.

DePuy would not comment on how much it had paid in recall-related costs. But spokeswoman Mindy Tinsley told The New York Times that the company is working with patients and insurers.

Along with ASR-related cases, DePuy also faces more than 560 lawsuits over the all-metal version of another hip model—called the Pinnacle. Since the model isperforming well, company executives have said that costs for its replacement are being borne by Medicare, insurers or by thepatients themselves.

To recoup their expenses, insurers typically notify patients through lawyers that they expect to be reimbursed from any settlement money patients receive, rather than pursue their own lawsuits with the device makers. Also, Medicare is expected to enforce new laws sometime this year that will make it easier for the agency to recover taxpayer dollars spent treating patients injured by problem drugs and medical devices, legal experts said.

Carticept Looks to Build Momentum for New Technology

Shaking up the status quo. When a new medical device firm—or any nascent company, for that matter—enters the market with a new product, the goal usually is to stand out, be different or put a new spin on the traditional.

For Timothy J. Patrick, president and CEO of Carticept Medical Inc., his motivation is no different.

This year’s annual meeting of theAmerican Academy of OrthopaedicSurgeons (AAOS) was the first opportunity for Carticept to highlight its newest product—the Navigator DS—following the device’s 510(k) clearance by the U.S. Food and Drug Administration in October 2011.

Navigator DS is a computer-controlled drug delivery system with integrated ultrasound guidance that is designed to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.

More than 46 million Americans have doctor-diagnosed arthritis, according to figures cited by the company. Local injections of corticosteroids and anesthetic agents are heavily relied on as early, effective interventions for pain relief. The current standard of practice depends on the expertise of the clinician and the accuracy with which the medications are injected into the affected joint space. A clinician, usually with an assistant, must manually pull the correct dosage of pain killer and steroid out of vials with a syringe that then is injected into the patient—a process that has remained unchanged for years.

However, a recent study published in The American Journal of Sports Medicine found that injection accuracy rates significantly are higher when imaging techniques are used in conjunction with injections to the knee and shoulder (both the top and main joints).

That’s where Carticept comes in.

“We’re not aware of any similar technology on the market,” Patrick said.

The system prepares and delivers physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials, eliminating needle exposures to healthcare workers and minimizing the potential for contamination of the medication. It also helps to ensure accurate dose preparation and saves significant labor for a busy physician practice, according to Patrick. The procedure can be conducted by the physician only.

The ultrasound system—provided in partnership with SonoSite Inc. (which also invested in Carticept)—provides the physician with real-time visualization of the needle position, fluid delivery process and prescription volume. After the injection is delivered, the system records the treatment data and automatically creates a record for transfer to an electronic record management system.

The entire unit is housed a compact, upright, mobile cart.

Patrick said that after examining data that indicated imaging of the process could improve accuracy and provide better outcomes, the need for a system became clear—particularly for smaller joints. The company was founded in 2005 to tackle the challenge and respond to a yet untapped market need.
The product development cycle took about three-and-a-half years. The company used in-house research and development staff for Navigator’s initial concept, but the company now uses in “a number of” design, manufacturing and engineering firms to produce the system, according to Patrick.

The company now has 40 employees, and is “ramping up its sales staff,” to prepare for the full rollout of the Navigator, Patrick said, adding that the company has about 15 sites using its technology at the moment. Carticept will solicit feedback from the system’s initial users, make modifications as appropriate and then expand for a wider launch around April.

Ben DuBois, M.D., orthopaedic surgeon at Grossmont Orthopaedic Medical Group in La Mesa, Calif., told Orthopedic Design & Technology that the device, which he has incorporated into his practice, has “significantly” improved efficiency.

“It allows me to free up an assistant to, for example, to take vitals from the next patient or other important tasks,” DuBois said. “I can do this myself, accurately and efficiently. It makes the patient experience so much better.”

DuBois added that because of the increased accuracy of injection placement, patients seem to be experiencing less pain and discomfort. “Plus, they can see the placement and be confident that they’re receiving the appropriate dosage in the best location,” he said.

In addition to its use in sports medicine and orthopedics, Patrick believes the technology has future applications in anesthesiology, radiology and other specialties that require accurate dose delivery.

“The clinical response has been very encouraging,” Patrick said. “We’re looking forward to exploring additional indications armed with solid data and outcome in this market.”

Carticept Medical Inc., based in Alpharetta, Ga., is a privately held, private equity-backed firm. Major investors in addition to SonoSite include Domain Associates and New Enterprise Associates. The company closed a $10 million Series C round of funding in January.

In addition to Navigator, Carticept Medical distributes SonoSite ultrasound products to the orthopedic marketplace. The company’s first product was Cartiva synthetic cartilage implant (SCI), designed to replace or repair worn or damaged cartilage. The implant is made of a proprietary biomaterial with wear and other physical properties similar to human cartilage. Cartiva SCI currently is available in Canada, Europe and South America, but has not yet beenapproved in the United States.

Medical Device Accelerator Program Launches in Memphis

Navigating the waters of medical device product approval can be challenging to say the least, even for experienced industry professionals and established medicaldevice companies. But the challenge can be that much steeper for first-time entrepreneurs who have an idea but lack the necessary experience.

A new program from the Memphis Bioworks Foundation in Tennessee has been launched to give some of these nascent companies and device ideas the tools to run the U.S. Food and Drug Administration approval gauntlet. Applications for a program called “ZeroTo510,” which is designed to help entrepreneurs bring medical device products and companies to market, are open through April 5.

ZeroTo510 is a unique, entrepreneurial accelerator program that focuses on leveraging the regional strength of the Memphis area in medical device research and manufacturing, according to program organizers. The goal of ZeroTo510 is to help medical device entrepreneurs navigate the startup process, refine business models and—as the program’s name implies—achieve the FDA’s 510(k) pre-market notification filing.

Through a competitive application process, six companies will be selected to participate in an intensive, mentor-driven, 12-week program of instruction and hands-on activities. In addition, each company chosen for the program will receive $50,000 in seed capital from Innova, a pre-seed, seed and early-stage investor founded by Memphis Bioworks in 2007 and focused on starting and funding high-growth companies in healthcare and technology in Tennessee. The seed capital also is funded in part by MB Venture Partners, a Memphis-based venture capital firm that provides equity capital and strategic direction to life-science startups.

The program was launched by Innova and Memphis Bioworks Foundation, a not-for-profit organization that leads collaboration among public, private, academic, and government entities to accelerate the growth of the bioscience industry in the Memphis region. ZeroTo510 is an initiative of the Greater Memphis Accelerator Consortium, a startup Tennessee affiliate program funded by the State of Tennessee Economic and Community Development Commission.

“ZeroTo510 is the first-ever programof its kind in the United States focusedon medical devices,” said Allan Daisley,director of innovation and sustainability initiatives for Memphis Bioworks. “An entrepreneurship program for medical devices is an ideal match for the resources and talents of the Memphis area. Typically, it can take years for ideas to pass through regulatory hurdles. An accelerator program that focuses on the 510(k) filing is the right approach to achieving an expedited path to market, but achieving success in that path requires unique skills and knowledge. ZeroTo510 will provide that.”

At the end of the 12-week program, the participants will pitch to a group of investors. The investors will select up to three finalists, who will receive as much as $100,000 in additional capital infusion and the opportunity to further develop their business and then present at the 10th Musculoskeletal New Ventures Conference in Memphis in October.

Competition for participation in the program is open internationally. However, companies selected must be Memphis-based or be willing to relocate to Memphis for participation.

“Those who are already Memphis-based know the resources and talent available to them here,” said Ken Woody, a partner with Innova and ZeroTo510 board member. “Those who relocate here will soon learn that Memphis is the right environment to launch and grow a medical device company, and we expect them to quickly develop connections here.”

Companies chosen for participation will be notified by April 12. The program will begin on May 12. Information on applying and additional data about the ZeroTo510 program is available at www.zeroto510.com.

Stryker Showcases New Products at Academy Meeting
Each year, the American Academy of Orthopedic Surgeons brings together incredibly diverse members of the orthopedic community—healthcare providers, manufacturers, suppliers, consultants, analysts and so many others.

It’s always a venue for new product releases. This year’s event was no different.

Stryker Corp. used the 2012 AAOS meeting to showcase a number of new product offerings. Also this year, the company is celebrating “75 Years of Innovation,” a reference to 1937, when the company’s founder, Dr. Homer Stryker, first began inventing and selling new medical device technologies in Kalamazoo, Mich. (where the company still maintains its headquarters).

Products highlighted at the annual meeting included new heavy-duty power tools. Company officials noted that the latest offering, called System 7, builds on more than 30 years of cordless surgical power tool development. System 7 offers cutting technology for large-bone surgeries.

Also released at AAOS was newcomputer-assisted surgery technology for trauma procedures. Stryker’s ADAPT System powers the company’s FluoroMap software and provides adaptive positioning technology for the Gamma3 locking nail system.

On the implant side, Stryker featured new products for spinal surgery and shoulder arthroplasty.

The Aria spinal system provides a solution for minimally invasive, transpsoasaccess and spinal implant delivery with an open neuro-monitoring strategy. In addition, the AVS Anchor-C cervical cage

system is designed for anterior cervical fusion procedures in adults (the company calls these folks “skeletally mature”),featuring an integrated design that allows for rigid screw fixation without any added anterior profile.

The ReUnion total shoulder arthroplasty modular system uses“revolutionary implant technology and thoughtfully designedinstrumentation,” according to the company. Stryker officials claim the implant includes the first highly crosslinked polyethyleneglenoids on the market. (A photo of theimplant is featured on the cover of this issue.)