Integra Lifesciences Holdings Corp. (Plainsboro, NJ), a firm with a diverse array of interests best known for its artificial skin technology, has agreed to buy Kinetikos Medical Inc. (Carlsbad, CA), a specialist in surgical devices for small bones, for $40 million in cash, Reuters News reports. Kinetikos was named one of MD&DI’s 50 Companies to Watch in the June issue. I’ve always kept an eye on Integra since I started covering life sciences for a New Jersey newspaper 10 years ago. Back then I did a feature on its artificial skin technology and other projects it had in development. I was impressed by what the company was up to but shocked that it wasn’t getting much recognition from Wall Street or the public. That started to change a year later when Wall Street veteran Stuart Essig was hired as CEO. Essig and his team have gotten Integra the high profile it deserves, and built it into a multi-market, multi-technology player. If they like what they see in Kinetikos, chances are Kinetikos is really doing something right.
DeviceTalk will return on Wednesday, July 5.
Baxter Healthcare Corp. has signed a consent decree with FDA to stop making and distributing two brands of infusion pumps until manufacturing deficiencies are corrected. The models are the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump. The action stems from a June 2005 inspection that found inadequate management controls over quality system operations and CAPA procedures, as well as design defects. The management-controls issues had also been raised during inspections conducted in 2000 and 2002. During the 2005 inspection, Baxter placed a worldwide hold on both products after the design defects were discovered. CDRH has always been suspicious about the reliability of infusion pumps, and this incident will reinforce that.
The New York Times reports that a Sanford C. Bernstein & Co. analysis predicts that the pricing power that makers of artificial hips and knees enjoy could diminish greatly soon. The Justice Department’s antitrust investigation may force prices to be made public. Currently, hospitals have no idea what others are paying for the devices, which has led to some unusual pricing practices. Greater transparency would be good for consumers, if not for the shareholders of the manufacturers.
Writer Daniel Stark has a touching story this week in the Washington Post about his experience with Parkinson’s Disease, and he sings the praises of Medtronic’s deep brain stimulation technology. He says he’s tried every drug treatment there is but none was as effective as the Medtronic device, which is implanted in the brain. He even offers the company suggestions for improving the design. It is pieces like this, which show how medical devices affect an individual person’s life, that will go a long way toward convincing the public and the government of the value of medical technology.
FDA has unveiled the Human Subject Protection and Bioresearch Monitoring Initiative, which aims to modernize the regulation of clinical trials and bioresearch monitoring in the device, drug, veterninary products, food, and biologics industries. This is part of the agency’s Critical Path Initiative to get important health technologies to market more efficiently. Conducting clinical trials properly and choosing the right clinical endpoints have never been more important to the success of a device company. The new initiative underscores that and is something that must be paid attention to.
Four orthopedics companies announced that they have received subpoenas from the Justice Department as part of a probe into possible antitrust violations, the Associated Press reports. The firms are Biomet, Johnson & Johnson’s DePuy, Stryker Corp., and Zimmer Holdings. All saw their share prices drop yesterday. This could get ugly.
Boston Scientific has recalled 23,000 pacemakers and implantable cardioverter-defibrillators made by Guidant because of a faulty electrical component that could cause the devices to fail, the New York Times reports. No deaths have been reported as a result of the problem, and the company estimates that only two or three of the devices already implanted in patients may have the defect. Yet the news was enough to send the firm’s share price down 5.6% yesterday, as Wall Street analysts grow more pessimistic about the company’s ability to overcome quality problems. But Boston Scientific made itself what it is today by challenging expectations and defying conventional wisdom. It will need more of that magic, in spades.
After the Wall Street Journal reported that some leading U.S. hospitals have cut back on use of drug-eluting stents because of concerns they could cause blood clots, shares of the makers of the two U.S. drug-eluting stents, Johnson & Johnson and Boston Scientfic, dropped on the news. This despite the Journal saying that the hospitals are not “drastically curbing” their use. Wall Street traders aren’t the only ones who may have misinterpreted the news: Last week a friend who saw the report mentioned to me about the products being “dangerous,” when the article said no such thing. The concern is that the polymers used to elute the drugs might be causing clots. But there is no definitive proof yet, nor is there evidence that those risks, if they exist, outweigh the benefits of the enhanced performance drug-eluting stents bring compared to bare-metal stents. So bring on more research, and let this be a reminder how even accurately reported bad news can become overblown quickly.
An FDA analysis conducted last year concluded that Guidant implantable cardioverter-defibrillators were 10 times more likely to fail than the company had let on, Bloomberg News reports, citing documents unsealed as part of a product-liability lawsuit against Guidant (now part of Boston Scientific) in Texas. When Guidant began its recall, it said that no more than 292 of the devices would fail. But the FDA analysis placed that figure at around 3200. This could be bad news for Boston Scientific, which assumed Guidant’s liability and is now looking at a stronger case against it. Would Jim Tobin and co. do it all over again? You have to wonder.
FDA’s San Francisco District and AdvaMed have announced a public workshop on device regulations, geared toward assisting small and start-up manufacturers. It will be held July 12-13 in Fremont, CA. Too many firms, big and small, seem to have trouble completing flawless applications and following every step of the QSR. Events like this can be a big help. An online registration form is available.
