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MIV Therapeutics Inc. reports that its stent with a drug eluted not by a polymer but by a ceramic shows promise after nine months of being placed in humans for the first time. The clinical investigator said the results suggest that the Vestasync DES will have a better safety profile and a similar efficacy profile to competitors already on the market. Notable is that the 0.6-micron ceramic coating enables 60% less drug to be used. Is this what the DES market needs to revive itself?

Zimmer Holdings, one of several orthopedics companies under fire for making payments to doctors that raised conflict-of-interest issues, said it has banned company personnel from making gifts to doctors. The firm said it is also banning physician endorsements, suspending payments to some of its consultants, reviewing royalty payments, and taking steps to prevent sales and marketing employees from having contact with doctors that consult for the firm, reports Bloomberg News. The company will also conduct its charitable giving through independent third parties.

Zimmer was one of four orthopedics firms that paid a combined $311 million to the U.S. government to settle claims of antikickback violations. It is one of five that agreed to have its physician-payment practices undergo federal monitoring. In exchange, the Department of Justice will not pursue criminal charges.

DePuy Spine Inc. (Raynham, MA) just launched a new implant that is designed to resist anterior migration during posterior and minimally invasive spinal fusion procedures. The Concorde Bullet Vertebral Body Replacement was first released in July. The device makes it easier to insert collapsed vertebral bodies and restores height, and pyramid-shaped teeth help resist migration. It also minimizes insertion forces to reduce the risk of damage to vertebral bodies. The implant is made with a carbon fiber-reinforced polymer, which allows for enlarged lateral openings.

Zimmer Holdings announced that it is recalling some orthopedic surgical products made in its Dover, OH plant because of failure to meet internal quality standards, particularly those regarding packaging, the Journal Gazette of Fort Wayne, IN reports. The plant makes products used to support orthopedic surgery, including bowls and paddles used for mixing bone cement. Though the firm’s core hip- and knee-implant products are not affected, it still expects the recall to reduce 2008 revenue by $70-80 million.

Last year, the U.S. large joint reconstructive implant market for hips and knees was worth almost $6 billion. That’s nearly a 10% growth over 2006. A report by Millennium Research Group (Toronto) on this market indicates that the progress stems from procedural growth (as a result of an aging population) and an increase in average selling prices (ASP) of implants.

“For orthopedic manufacturers to respond to this growth, they want to grow the potential patient population,” says Andrea Cheng, senior analyst in the orthopedics division at Millennium Research. “It seems like these days, the focus is on developing products that are catered not only towards your typical aging population, but also target younger and more active patients.”

More than half of 2007’s total revenue came from knee implants, a segment that’s anticipated to experience strong growth through 2012. Factors contributing to the success include more patients ages 65 and older, along with young and active patients, and more wear-resistant implant components. It’s also expected that there will be greater acceptance among surgeons in the area of hip and knee cementless implants.

The reconstructive hip implant sector, which was valued at more than $2.4 billion, could achieve double-digit growth through 2012. This increase can also be attributed to further acceptance of wear-resistance components as well as the adoption of hip resurfacing implants. Cheng notes that most of the hype surrounding hips concerns resurfacing and alternative bearing surfaces.

Hip resurfacing appeals to younger and active patients, mainly because it preserves bone, leaving more intact for future revision procedures. “This is growing the overall patient base,” says Cheng. “It’s also impacting ASPs, because these kinds of implants are priced higher than your typical primary total hip implant.”

Another example of innovative products leading to a wider patient base is alternative bearing surfaces. Manufacturers like Smith & Nephew are looking into hybrid materials. The company’s Oxinium material combines ceramic and cobalt chrome, and is used in the components of hip and knee implants.

The orthopedic market continues to be dominated by the big five–Zimmer, DePuy, Stryker, Smith & Nephew, and Biomet. Millennium Research estimates that these companies comprise about 90% of the market. Cheng doesn’t see a shift in competitors happening any time soon and adds that the most important factors for the large companies will be their ability to differentiate themselves from each other.

-Maria Fontanazza

During this year’s annual meeting of the American Academy of Orthopedic Surgeons in San Francisco, DePuy Orthopaedics Inc. showcased several new products.

Sigma Knee: Additions to this product line include instruments designed to increase efficiency, surgical precision, and flexibility during knee surgery. The compact design of the instruments enable smaller incisions and are soft-tissue-friendly to reduce trauma. DePuy plans on releasing more Sigma Knee products during the next 18 months.

Pinnacle Hip Solutions with TrueGlide technology: This line includes high performance instruments, advanced implants, and materials to provide pain relief and a smoother range of motion for patients. The Tri-Lock bone preservation stem is a tapered-wedge titanium stem that preserves the anatomy by reducing the amount of bone removed during a hip replacement.

Anatomic Locked Plating Systems: In the orthopedic trauma segment, DePuy released small fragment, large fragment, and distal tibia plating systems. The titanium plate and screw system is a hybrid plate concept that helps surgeons stabilize fractures with nonlocking screws through a plate.

The Acrobot Sculptor, developed by UK-based Acrobot Co. Ltd., is a surgeon-controlled robot that can replace traditional instruments. Using the company’s Active Constraint technology, the system limits a bone-cutting tool to a defined space, which enables a surgeon to accurately shape the bone that is receiving the joint replacement implant. The concept of sculpting almost any shape opens the door to unique implant designs with minimal bone removal in a minimally invasive manner.

Acrobot develops precision surgical systems that are used for computer-assisted 3-D planning, visualization software, surgical navigation, and surgeon-controlled robotic procedures.

The investigation into arrangements between device companies and physicians didn’t end with last September’s settlement between the government and five major orthopedics companies.

In February, the U.S. Senate Special Committee on Aging held a hearing to focus on the financial relationships between surgeons and device companies. Witness testimony included representatives from Stryker Corp. (Mahwah, NJ), Zimmer Holdings Inc. (Warsaw, IN), and Applied Medical Resources Corp. (Rancho Santa Margarita, CA).

During the past few months, the committee spoke with several surgeons and sales people from the device industry. They learned that some doctors felt “shunned” after turning down participation in financial arrangements with industry, according to Senator Herb Kohl (D-WI), chairman of the committee.

While relationships between doctors and companies are an important part of the product development process, these interactions can be very complicated and risky.

“Device companies can legitimately compensate physicians for their actual time and intellectual contributions to product innovations and training in the appropriate use of devices,” said Gregory Demske, assistant inspector for legal affairs in the Office of Inspector General (OIG) at HHS.

However, when doctors are compensated by device companies via stock options, research grants, and other agreements, Demske noted there’s evidence implying that these payments run the risk of inappropriately influencing a doctor’s decision. He added it could also increase healthcare costs, lead to unfair competition, and compromise scientific integrity standards and medical research.

Charles Rosen founded the Association for Ethics in Spine Surgery in response to what he called an “increasing negative influence of industry” in treating back pain and spinal disorders. He told the committee about a dark side of the business in which he accused the orthopedic industry of discrediting him and threatening his job after he began voicing criticism for questionable practices.

The government isn’t just examining what companies are doing either. It’s also targeting doctors, and there are rumors, as reported in The New York Times, that physicians have received subpoenas. The issue was a hot topic at the American Academy of Orthopedic Surgeons’ annual meeting in March.

Demske pointed out that in January, Patrick Chan, a neurologist from Arkansas, paid $1.5 million in a civil settlement. He pled guilty to soliciting and taking kickbacks from implant manufacturer Blackstone Medical. The kickbacks included payment for fake consulting agreements and research studies.

As part of the effort to gain more transparency, Kohl and other senators introduced the Physician Payment Sunshine Act last year, which seeks to create a national database of payments and gifts to doctors.

AdvaMed has voiced its support for the legislation, on the grounds that some modifications are made to level the playing field for companies. Christopher White, executive vice president and general counsel for AdvaMed, provided some recommendations in his testimony before the committee. Among the suggestions were using a threshold for disclosure based on the level of payments that a company makes to a doctor each year, as opposed to the legislation’s requirement of disclosure only for companies reaching $100 million in annual revenue.

The investigation isn’t over, and the OIG and Department of Justice will continue to work together to prosecute against manufacturers and doctors who violate the laws. Demske added that the OIG will also maintain its outreach to companies and physicians to increase awareness and help them manage compliance risks.

-Maria Fontanazza

A study presented at the American College of Cardiology meeting found that drug-eluting stents are safe for heart-attack patients and may help their chances of survival, Bloomberg News reports. The Harvard Clinical Research Institute studied a database of more than 7,000 patients in Massachusetts. Those who received a drug-eluting stent were less likely to die or need a repeat procedure than those who received a bare-metal stent. Heart attacks caused by clots, deemed a risk from drug-eluting stents in earlier studies, were about the same in both groups.

A second study, from Italy, found that major heart complications occurred half as frequently for patients with drug-eluting stents as compared to those with bare-metal stents.

The key, however, is that DES patients take their anti-clotting medication as prescribed.

These results mean that perhaps doctors have gone too far in cutting back their use of drug-eluting stents, based on previous findings.

Abbott presented data claiming that its Xience drug-eluting stent, likely to receive FDA approval later this year, is more effective at preventing serious heart problems than Boston Scientific’s Taxus, the Associated Press reports. Abbott said its study, conducted over two years, found that Xience patients were 40% less likely to suffer an adverse event than Taxus patients, and were 44% less likely to suffer from reblocked arteries. Of the 300 patients in the trial, 6.6% of Xience patients suffered an adverse event, while 11% of Taxus patients did. Boston Scientific, which under a licensing agreement will distribute a version of Xience called Promus, said the results were not statistically significant.