Kensey Nash Corp. (Exton, PA), best known for developing the Angio-Seal and licensing it to St. Jude Medical, is buying, not selling, for once. In a release published on devicelink.com , the cardiovascular devices and biomaterials maker announced it has acquired IntraLuminal Therapeutics, Inc. (ILT; Carlsbad, CA) for $8 million.
Earlier this week, CDRH announced it will pursue an optional MDUFMA goal regarding 510(k)s but not one regarding PMAs. For fiscal year 2007, it aims to render a final decision for 80% of 510(k) applications within 90 days. It declined to set a goal of a final decision for 50% of PMA applicaitons within 180 days. AdvaMed and the Medical Device Manufacturers Association gave the news a lukewarm response. The docket for comments is open for about another month. Information about filing comments is available here .
In recent years, device therapies have emerged in some treatment areas that had been the exclusive province of drug therapies. The latest is moderate to severe asthma. The Associated Press has a report on a new procedure called bronchial thermoplasty, which uses an ablation device to burn off lung tissue that is blocking the patient's ability to breathe. The therapy is too new for its long-term effects to be known, but doctors seem enthusiastic about it.
CDRH has announced the launch of the Medical Device Innovation Initiative , which is the center's contribution to FDA's Critical Path Initiative to get new technologies to market more efficiently. The initiative includes three major efforts: promoting scientific innovation in product development, focusing device research on cutting-edge science, and modernizing review of innovative devices. The initiative shows a lot of foresight and presents a lot of challenges. A collaborative FDA-industry relationship will be needed now more than ever.
Finally, a mainstream mediaÂ article dismisses the concept of "zero risk" for medical devices.
Conor Medsystems Inc. (Menlo Park, CA) announced that the first patient has been treated with its stent that can deliver two drugs at once. In a release available on devicelink.com , the company said it has begun a trial comparing stents that elude pimecrolimus with stents that elude both pimecrolimus and paclitaxel. The former is an anti-inflammatory and the latter is an anti-proliferative.
The New York Times has an article about how the crisis with a Bausch & Lomb contact lens cleaner started in Asia last year but wasn't noticed in North America until much later. Is this going to be another case study of how analysis of adverse event reports needs to get faster and better?
Today's Boston Globe has a piece on Boston Scientific's campaign to make the Guidant brand name disappear following the acquisition of the troubled firm. At this week's Heart Rhythm Society conference, the Guidant logo appears on small signs beneath a Boston Scientific banner. At future events, it will be gone altogether.
At yesterday's FDA Centennial celebration in Philadelphia, Robert O'Holla, vice president of regulatory affairs for medical devices and diagnostic products at Johnson & Johnson, said something during his presentation that sums up my problem with much mainstream media coverage of the device industry: "The Internet has taken over, and the public knows more. The press feeds its thirst for knowledge. But it has also planted the seeds of mistrust. It has fostered the public's expectation of zero risk, which makes things impossible for regulators and industry.
The results are in: drug-eluting stents in the market tend to be clinically equal. That's the conclusion reached by ECRI , a nonprofit health services research agency in Plymouth Meeting, PA.
The Star Tribune of Minneapolis-St. Paul, MN has an article about an interesting proposal from the Heart Rhythm Society, contained in its report discussed in this space earlier: Eliminating the word "recall" when advising the public about a medical device malfunction. The word "recall" tends to cause alarm because it implies that the product is unsafe and the problem is so serious that the product must be fixed or replaced immediately.
A federal judge has upheld two separate jury verdicts involving stent patents. One found Johnson & Johnson in violation of a Boston Scientific patent, and one found Boston Scientific in violation of a J&J patent, the Associated Press reports. J&J is appealing the ruling against it, which means it will probably be a while before compensation or damages payments are decided.
Zimmer Holdings has received FDA approval for the first knee replacement designed specifically for a woman's anatomy . The Gender Solutions High-Flex Knee is designed based on three proven characteristics that distinguish a woman's knee from a man's: a narrower shape, a thinner shape, and a need for more natural knee motion when walking. This may be one of the first fruits of a trend to design gender-specific devices.
After a year of criticism over its doctors' ties to the drug and device industries, the Cleveland Clinic is taking steps to address potential conflicts of interest, the New York Times reports today. This includes creating a database to flag potential conflicts and settingÂ up a committee to address them.Â Not surprisingly, the Times makes no distinction between drugs and devices, despite the fact thatÂ clinician participation is essential to device development.
With the aim of increasing payment accuracy, CMS has proposed the most radical changes in payments for hospital inpatient procedures in a generation. But AdvaMed feels they may be misguided. After reviewing the proposals, AdvaMed's Executive Committee issued a statement expressing concern that they could reduce, not increase, payment accuracy and impede innovation. Part of the problem is that DRG calculations are based on old data that doesn't even account forÂ newer technologiesÂ like drug-eluting stents.