Medical Device Link The Online Information Source for the Medical Device Industry.

A study published in the Journal of the American Medical Association found that Medicare patients who received drug-eluting stents had a lower rate of heart attacks and repeat procedures than those who got bare-metal stents. The study followed patients who received stents in 2002 and 2003 — the latter being the year Cordis’s Cypher became the first drug-eluting stent approved for the U.S. market. It compared patients who received stents between October 2002 and March 2003 (100% of which had bare-metal) with those who got them between October and December 2003 (61.5% of which received Cypher.) The later group had a 19% rate of repeat procedures and a 2% rate of heart attacks, compared to the earlier group’s 22.8% and 2.4%. Death rates for both groups were the same, 8.4%.

The study, like several before it, may help alleviate fears about the safety of drug-eluting stents. Those fears were inflamed when a study published in 2006 linked them to increased blood clots. Now, it appears that, provided patients take their anti-clotting medications, drug-eluting stents may have a better risk-benefit profile than their bare-metal counterparts.

Despite Zimmer’s strong marketing campaign to advertise its Gender Solutions knee implant for women, patient outcomes have been similar to those receiving unisex knee implants. This is according to a Kaiser Permanente surgeon who analyzed 20,000 implant procedures (men and women) between April 2001 and March 2006. The debate over the need for the gender-specific implant has been present since it was approved two years ago, but the product has been successful regardless. Zimmer reported an 11% increase in knee sales for this year’s first quarter compared with last year at $454 million.

The Journal Gazette also reports that the American Academy of Orthopedic Surgeons has reviewed research related to the postsurgery failure rates of traditional knee implants in women versus men but found no consistent difference. The work was in efforts to investigate whether there is a need for gender-specific knee implants. The academy has no official stance on these types of implants, the article notes.

Some doctors believe it doesn’t, according to a piece in the Boston Globe. Some doctors favor it for younger patients instead of doing a total hip replacement at that point, because younger patients are likely to outlive their implants, and revision surgeries are easier after resurfacing than after a total replacement. But others are concerned about the lack of long-term data and the procedure’s slightly higher failure rates in the first 1-5 years compared to total replacement. They also point out that resurfacing is a tougher operation than a total replacement because there is more blood loss and the incision usually has to be larger.

Now that the procedure is reimbursed in the United States, it is probably here to stay, so time will tell the initial data is due to surgeon inexperience, or whether something more significant is at play.

DePuy Spine Inc. (Raynham, MA) has announced the launch of its next generation anterior cervical fixation systems. The devices use new screw-locking technology and provide more plating options for anatomically challenging surgeries. The EAGLE Plus Micro Plate is made for short, one-level constructs in awkward places like the C2- C3 (cervical vertabrae levels). The SWIFT Plus Dynamic Anterior Cervical Plating system has a corpectomy plate that is made for maximum visualization and contouring on longer corpectomy constructs. According to a surgeon designer from Commonwealth Orthopaedics (Fairfax, VA), the combination of both products produces a system that is one of the most versatile available for treating multiple diseases of the cervical spine.

A recently published study finds that older total hip arthroplasty patients double their chances of improving physical function and independence versus those who don’t have the surgery. Conducted at the Duke University Medical Center, the study also revealed that the procedure saves the healthcare system money, since reimbursement is cheaper than long-term care for a disabled patient. Such care can add up to about $50,000 annually.  Although many doctors shy away from recommending total hip replacements to much older patients, the procedure is just as beneficial to those in their 80s or 90s as it is for patients in their 60s, according to Linda George, PhD, from Duke. Fewer than 25% of patients who could be helped by the surgery opt to have it. George says doctors should be confident in recommending the surgery to those who need it, because the outcomes lead to less pain and an increased range of motion.The Institute for Health Technology Studies provided a grant for the research. A podcast featuring Linda George can be found here.

Despite the decline in sales of drug-eluting stents in recent years, Boston Scientific Corp. anticipates the market will improve. The company’s CEO, Jim Tobin, even told investors that he expects patient flow in this sector to be “robust,” but not enough to reach its once strong $6 billion level. Market penetration might not even reach 88% again, Tobin said, but it’s not going to stay at 60% either. Medical device executives suggest studies that are showing the safety and effectiveness of stents could push a slow recovery in sales as well, according to the Associated Press.

Boston Scientific’s first-quarter drug-coated stent sales fell 9% to $428 million, while its ICD sales reached $411 million, a 3% increase.  

Datascope Corp. announced that it is acquiring a peripheral vascular stent business, and related intellectual property, from Italy-based Sorin Group. Financial terms were not disclosed. Datascope has been undergoing a shift in business focus, and has indicated that it may end up selling itself. It sold off its patient monitoring business and has decided to focus on products for the cardiology and radiology, cardiovascular and vascular surgery, and critical care markets.

Esophageal stents, which help patients with esophageal cancer eat and swallow better, have been around for many years. But the technology hadn’t advanced in a number of years, so its pitfalls hadn’t been rectified. Now, however, that may change, as Cook Medical has introduced the Evolution Controlled Release Esophageal Stent System, which was designed in collaboration with U.S. and European doctors with addressing the technology’s drawbacks in mind. These drawbacks sometimes meant the stents could not be delivered properly, or that tumor ingrowth would occur, necessitating repeat procedures.

According to Barry Slowey, vice president of global sales and marketing for Cook’s endoscopy division, the design improvements include:

* Making the shape resemble a dumbbell, rather than a cylinder, and not coating the ends of the stent, to better keep the stent lodged in place. These steps could prevent it from migrating out of the esophagus, which would cut back on procedures to remove wayward devices.

* Coating the stent with a silicone instead of polyurethane, which most previous products use. “We found that polyurethane does not do well in a very acidic environment, and these patients often have a lot of acid reflux,” says Slowey. “We found the best alternative is silicone, which has been used for years on feeding tubes.”

* Coating the stent on the inside and outside, instead of just the outside. If the inside of the stent is not coated, food can get stuck in it, which can lead to sepsis.

* Developing a completely new delivery mechanism. With existing products, once they were unfurled even a small amount, they could not be repositioned. The Evolution comes with a “pistol-grip type delivery mechanism,” says Slowey. “Each time the physician squeezes the `trigger,’ the stent, which is 8-15 cm in total length, deploys 8 mm. So you can squeeze, then look at the flow, then squeeze, then look at the flow, so the deployment process is more accurate. We also put a button on the handle that reverses the mechanism, like you see on a drill. Up until it’s 50% deployed, you can recoil the stent 8 mm at a time, reposition it, and start deployment again.”

These advances should not only make the product more comfortable for the patient, but they could save costs through fewer stents wasted because of deployment errors and fewer repeat procedures, Slowey says. Yet, he notes, it is priced similarly to existing stents, so that hospitals won’t cite upfront costs as a reason not to switch. “We think this will be a disruptive technology and shake up the market,” he says.

– From DeviceTalk.

It’s very possible and is a cause for concern. There’s no doubt that knee replacements are improving the quality of life for patients every day. But now the popularity of the procedure is increasing to the point that experts wonder if demand will soon surpass the amount of surgeons who can perform the surgery. The number of knee replacement procedures dramatically rose from between 300,000 and 350,000 a few years ago to 500,000 today, according to the University of Michigan Health System. It’s estimated that in ten years, the annual number could reach 3.2 million. J. David Blaha, MD, an orthopedic surgeon at the University of Michigan, suspects this could become a problem of “epic proportions.” One study that examined trends in joint replacement revealed that while there will be a 2% increase in orthopedic specialists, the need for orthopedic surgeons will increase by 500%.