Posted 10/31/11 on Medical Device Daily.
Cook Medical’s Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies.
I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had seen in some time. Cook presented a clear study that met all primary endpoints and showed improvement over percutaneous transluminal angioplasty, the current standard of care. To non-FDA experts like myself, it seemed as though Cook was recognized for setting a new bar for conducting clinical trials and collaborating with the FDA.
I imagine that Cook Medical’s leadership was able to make all the right clinical trial investments necessary for the long-term viability of the product’s market value, not just the ones that were on display at the advisory panel meeting.
Continue reading “Buck for the Bang: Premium Med-Tech Pricing”
First posted 8/11/11 on Gooz News
The Institute of Medicine report on medical device regulation released two weeks ago called for scrapping the 510(k) process that allows for market entry of new devices if they’re shown to be “substantially equivalent” to already marketed devices. In a Perspective in today’s New England Journal of Medicine, committee members David R. Challoner, M.D. of the University of Florida and William W. Vodra, J.D., an attorney at Arnold & Porter, reiterated the reasoning of the report:
Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing 2 years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976. But that original device might never have been assessed for safety or effectiveness, nor perhaps would any subsequent ones in the family tree. . . We decided that the 510(k) process cannot be transformed into a premarketing evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to a previously cleared device.
Continue reading “Alternatives To Scrapping 510(k)”
First published 6/07/11 in The Fiscal Times
While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.
The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices – from heart valves and defibrillators to artificial knees and hips – are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.
Continue reading “Soaring Medical Costs Pinned on Medical Devices”
First published 2/14/11 on Gooz News
Over the past several months, as my colleague Allison Bass pointed out last week, the medical device industry has launched a preemptive campaign to blunt the Food and Drug Administration’s long overdue overhaul of the way it approves joints, stents, pumps and other medical devices inserted in millions of American bodies every year. Triggered in 2009 by the ReGen Menaflex scandal, the FDA device review over the Obama administration’s first two years focused on the 510(k) approval process, which allows devices deemed substantially equivalent to previously approved devices to slide through their FDA approval process without undergoing clinical trial testing in humans. Recognizing that the law had created a huge loophole for devices whose malfunctioning would pose a serious risk to human health, the FDA asked the Institute of Medicine to conduct a full-scale investigation into the device review process. That report is due in June.
Continue reading “Medical Devices: PR vs. Reality”
Originally published 1/17/11 on Health Populi.
The U.S. has few bright spots when accounting for global trade: we import much more than we export. Entertainment is America’s #1 export. After that, medical innovation shines.
Continue reading “Health Innovation In The US Is Ours To Lose”