The Times of Trenton, NJ has a nice feature about MicroDysis (Trenton), a three-year-old startup that is developing a microscopic peristaltic pump for drug delivery. Its founder, Joseph Huang, has been given The College of New Jersey’s Small Business Development Center Success Award. He has done some groundbreaking work in microfluidics, which led to a patent and a strong outlook for the fledgling company, which is projected to generate $30 million in revenue over the next five years. It’s important that young, innovative companies get recognition when they succeed; they need all they can get to keep them going.
The Cleveland Clinic analyzed the data 14 studies covering 6675 patients and concluded that drug-eluting stents are 4-5 times more likely to cause blood clots than bare-metal stents, reports Reuters. The researchers conclude that there is “a small but real hazard of late stent thrombosis with drug-eluting stents.” The findings, published in the December issue of the American Journal of Medicine, are sure to make next week’s meeting of CDRH’s Circulatory System Devices Panel even more interesting. The meeting, scheduled for Dec. 7-8, could produce some consensus among FDA and doctors about the safety issues related to drug-eluting stents. It could go a long way toward determining future levels of use in the United States. Industry has a lot at stake here.
Medtronic yesterday lost its bid to dismiss the hundreds of lawsuits filed against it in the wake of last year’s recall of implantable cardioverter-defibrillators with faulty batteries, the Star Tribune of Minneapolis reports. Medtronic argued that because its devices need to undergo such rigorous testing to gain FDA approval, state negligence and product liability laws should not apply. But a federal judge sided with plaintiff lawyers, who argued that Medtronic had known about the faulty batteries for two years before reporting the problem to FDA. No deaths or injuries have been reported as a result of the problem. Medtronic is likely to appeal the decision.
UPDATE: On Wednesday night, the Star-Tribune published a story speculating that out-of-court settlements could be in the cards.
The Associated Press has a feature on the Watchman, an experimental device that could prevent those with atrial fibrillation from getting strokes. The condition causes an irregular heartbeat, which can cause blood clots to be shot to the brain, causing stroke. The current treatment is the blood-thinning drug Coumadin, which is hard for many patients to tolerate. It so happens that the majority of the potentially fatal clots collect in a flap of tissue that hangs over the left atrium. The Watchman seals off that flap, depriving clots of their staging area. Whether it prevents strokes is yet to be seen, but early results are encouraging. What’s not encouraging is that the AP made no mention of the company that developed the device, Atritech, Inc. of Plymouth, MN.
Those who are most likely to die from coronary artery disease are those who have what is called “vulnerable plaque,” a form of plaque prone to rupture. But as of now, little is known about how it forms, what causes it to rupture, and who is likely to get it. So, reports the New York Times, drug, genomics, health insurance and diagnostics companies are teaming up to fund a $30 million research program that hopes to get to the bottom of these questions. Contributing on the diagnostics side is Phillips, which is expected to provide computed tomography equipment to scan the hearts and arteries of the 4,000 to 6,000 patients in the project. On the device side, Abbott has a separate 700-patient study on this topic, inherited from Guidant when it bought that firm’s stent operations. It’s not clear what these studies might yield and whether devices can be of help to whatever is learned. But it’s important they proceed.
After having its best month on record in October, Cook Group’s endovascular unit appears to be a force to be reckoned with. Barry Thomas, director of the strategic business unit, presented promising data during its media and analyst briefing last week in New York. So far, 2006 global sales in the endovascular unit are up more than 22%, with strong growth coming from markets in Asia and Latin America. Cook’s abdominal aortic aneurysm (AAA) stent graft, Zenith, is a strong competitor in the endovascular sector and was recently launched in Japan (it’s also is the first and only such device there). And out of the 6200 AAA stent grafts implanted in the United States in the third quarter, the Zenith endograft came in second with 37% of the market, behind Gore’s graft by a mere 1%. However, during the same quarter in Europe, Zenith was at the top with 47% of the market and a 15% lead. Cook’s endovascular unit has also expanded in Japan, Taiwan, and South America, and is positioned in what Thomas labeled the “emerging” markets of China, India, and Korea. The division is also keeping endovascular disorders such as disease in the ascending aorta and thoraco-abdominal disease on its radar screen for future device development.
It has long been assumed that of all available vision-correction options, laser eye surgery is the most risky. But now, reports the Boston Globe, some ophthalmologists are saying that, over the long term, contact lenses are slightly more dangerous than laser eye surgery. Over the past 10 years, the complication rate for the surgery has dropped significantly, as surgeons have gained more experience and equipment and antibiotics have improved. Meanwhile, with contacts, the longer they are in use, the greater the chance of a problem from leaving them in too long or failing to follow cleaning procedures.
Today’s New York Times has tales of two medical device CEO departures, but their stories are very different. Zimmer Holdings announced that CEO Ray Elliott will retire in the first half of 2007. He has led the firm since its spinoff from Bristol-Myers Squibb, and made it a force in minimally invasive orthopedic surgery. Under his leadership, Zimmer was named one of MD&DI’s Medical Manufacturers of the Year in 2004. Cyberonics CEO Robert “Skip” Cummins is also leaving his post, but under less auspicious circumstances. He had come under fire for the timing of a stock-option grant he received in 2004. Cyberonics’ board granted him 100,000 shares just hours after FDA approved the company’s implant to treat depression, and the value of the shares soared the next morning. CFO Pamela Westbrook also resigned. Some analysts speculate that Cummins’ departure clears the way for Cyberonics to be sold, as rivals Advanced Neuromodulation Systems and Advanced Bionics have been in recent years.
It would have been easy for FDA to maintain the 14-year ban on silicone-gel breast implants. The ban had a number of vocal proponents, and the controversy from the early 1990s is still fresh in the minds of many. But on Friday FDA made the hard, but correct, choice to allow the implants back on the market, after years of research by the agency and the Institute of Medicine showing that the devices don’t cause major illnesses. They are prone to rupture, however, and CDRH Director Daniel Schultz advises potential users to keep that in mind. Upfront disclosure of potential issues, continued disallowal of their use for cosmetic reasons for women under 22, and mandated postmarket studies by manufacturers Allergan and Mentor should be enough to assure that the implants are used as safely and effectively as possible. Consumers should remain vigilant, however, and FDA has given them a head start by providing a list of useful information about the Allergan and Mentor products. Part of FDA’s job is to keep patently unsafe products off the market. But that does not extend to banning any product that might present some risks, as there is no such thing as a zero-risk medical device. As long as the science shows that silicone implants are not patently unsafe, and that research will continue to occur, it’s best to let consumers decide for themselves.
Johnson & Johnson announced last night that it plans to buy fellow stent maker Conor Medsystems (Menlo Park, CA) for $1.4 billion in cash, reports the Star-Ledger of Newark, NJ. The purchase price amounts to a 22% premium above what Conor shares are trading for. But it could be well worth it to J&J. Conor’s drug-eluting stent technology does not rely on polymers, which many believe are the culprit behind cases of clotting in patients with J&J’s Cypher and Boston Scientific’s Taxus. Instead, the Conor stent is riddled with holes that allow for a more direct and accurate eluting process. It is a logical step to the next generation of stenting technology, and J&J apparently did not have anything equally innovative in-house. If there are no obstacles with regulatory approval and due diligence, the transaction should close in the first quarter of 2007.
