FDA has approved two coronary stents: Abbott’s XIENCE V and Boston Scientific’s PROMUS, both of which are an everolimus eluting coronary stent system. The PROMUS is actually the private-labeled XIENCE V, which is made by Abbott but distributed by Boston Scientific. The stent props open the artery and releases everolimus. According to Abbott, a big part of FDA’s approval of XIENCE V came from favorable results achieved in a clinical trial in which the device showed “statistical superiority” to Boston Scientific’s TAXUS stent. Results of the two-year trial included (both compared to Taxus) a 45% reduction in the risk of major adverse events and a 32% reduction in the risk of target vessel failure.
XIENCE V is built on Abbott’s MULTI-LINK VISION coronary bare metal stent. It has been on the market in Europe for almost two years. Since Boston Scientific provides PROMUS, it is the first U.S. company to offer a dual, drug-eluting stent portfolio.
– From Device Talk
FDA has issued a Public Health Notification about complications related to the use of recombinant human bone morphogenetic protein (rhBMP) in cervical spine fusion, a use that FDA has not approved. At least 38 reports have been received by FDA during the last four years related to rhBMP use in cervical spine fusion. Complications, which could be life-threatening include difficulty breathing or swallowing, and swelling of the neck, tongue, mouth, shoulders, or upper chest. Most of the complications happened between 2 and 14 days after an operation, and some patients required respiratory support and second surgeries to drain the surgical site.
Cardiac catheterization was believed by some to not be effective in women — especially since women are underrepresented in clinical trials. A new study published in the Journal of the American Medical Association has dispelled that, at least for women who have suffered heart attacks, Reuters reports. Researchers analyzed results from eight trials covering 10,000 patients, comparing men to women. They found that women who had heart attacks and then received cardiac catheterization — which can include angioplasty and stenting — were 33% less at risk of death, another heart attack, or rehospitalization than a control group. The figure for men who had heart attacks was 44%. However, women who had unstable angina but did not suffer a heart attack showed no benefit from cardiac catheterization, while men in that category showed a modest benefit.
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.
