The device world and the high-tech world have collaborated on a portable system that programs pacemakers and implantable cardioverter-defibrillators. St. Jude Medical and IBM have launched the Medical Merlin Patient Care System, which helps clinicians conduct tests, analyze data, and better program implanted devices. It is a portable computer with a touch screen that allows doctors to retrieve data and make programming changes quickly while making visits to patients. Leveraging technology ideas from other industries is a good way to advance medical care, and this system appears to be no exception.
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. ILT makes the Safe-Cross System, which treats chronic total occlusions in coronary and peripheral arteries.
Kensey Nash has been named one of MD&DI’s 50 Companies to Watch and will be featured in the June 2006 issue.
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. Typically, however, the article focuses only on the doctors experimenting with the treatment and doesn’t even mention the manufacturer of the device — Asthmatx, Inc. of Mountain View, CA.
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 media article dismisses the concept of “zero risk” for medical devices. In his Boston Globe piece on last week’s Heart Rhythm Society conference, Stephen Heuser reports on discussions about how the risks of implantable heart devices need to be put in perspective. He comes to this conclusion: “The predominant message at the convention is that despite all the gee-whiz marketing, despite all the news coverage, despite all the regulation the government can dream up, doctors and patients can’t escape a fundamental truth of medicine: There’s no such thing as 100 percent sure.” Now if only more members of the mainstream media would get the message.
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. Experts have been saying that they foresee the day when stents are used to elute more than one substance. That day is here.
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. Even though many doctors say they don’t consider Guidant’s cardiac rhythm management devices riskier than those of their competitors, Boston Scientific is taking no chances. Guidant’s sales dropped after last year’s bad publicity, and the combined company can’t risk further erosion. Such is the cutthroat nature of the highest levels of the corporate world.
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. How can we get risk equation discussions to a level that the public can understand?”
There is no such thing as a risk-free medical device. Medical procedures by definition carry some level of risk. Yet somehow, the press has equated “safe and effective” with “zero risk.” While of course that should be aspired to, it’s impossible to achieve. The press, and through them the public, needs to be educated that “safe and effective” means “based on available information, risk is mitigated.” Until then, too much coverage of the device industry will be based on uninformed hysteria.
