Drug Eluting Stent News
News and Information About Minimally Invasive Medicine
PatientCenter
VascularTherapy.OrgBlogDiscussion Forum
Home » Stent News » March 5, 2007

Waxman's Congressional Committee
Requests Clinical and Marketing Information
About Drug-Eluting Stents from
Boston Scientific and Cordis


March 5, 2007 -- California Representative Henry A. Waxman, chairman of the House Committee on Oversight and Government Reform, announced today that he had sent letters last week to drug-eluting stent manufacturers Boston Scientific and Cordis Corporation. The letters began:
"Concerns about the safety and off label use of drug-eluting cardiac stents were raised by a recent FDA panel. As part of the Committee's ongoing oversight of the medical device industry's research and marketing practices, I am writing to request information about these concerns and drug-eluting cardiac stents."

The information requested was wide-ranging, encompassing all trials, studies and reports in which the companies were involved, both within and outside of the U.S., including not only the results, but any compensation paid to physicians or institutions. Much of this information (with the exception of the compensation data) previously has been presented at various meetings and is available from a variety of sources.

However, Waxman has also requested all materials relating to the marketing of these devices, including support for medical education programs and support provided to nonprofit professional medical organizations or consumer/patient organizations, such as the Cardiology Research Foundation (CRF), the Transcatheter Cardiovascular Therapeutics (TCT) meeting, which is organized by CRF, and the Society for Cardiovascular Angiography (we assume Congressman Waxman meant the Society for Cardiovascular Angiography and Interventions or SCAI).

Although both stent companies had been asked by the FDA to present clinical data about drug-eluting stents and late stent thrombosis at the December panel meeting, this is the first time that an official body has requested stent marketing information -- and specifically marketing information relating to the largest annual meeting of interventional cardiologists -- the TCT. Boston Scientific Corporation immediately issued a press release with the following statement:

"We look forward to providing the Committee the information it has requested. As the leading maker of drug-eluting stents in the United States, we have been -- and remain -- committed to providing physicians, patients and loved ones the information they need to make informed treatment decisions."

Cordis also sent out an email stating that they would cooperate with the Committee.

Waxman didn't give the companies much time. He requested that the information be delivered by March 21 -- a little over two weeks from now.

 


(Disclaimer: external links to news, press releases and other timely information sources are provided as a service by Angioplasty.Org, which is not responsible for the content found on any external sites. Items marked with a ($$) indicate that the external site normally restricts viewing to paid subscribers. Other sites may require free registration.

Angioplasty.Org Home •  PatientCenter


send comments & suggestions to "info at angioplasty dot org"
Read our Privacy statement.

Angioplasty.Org is an editorially independent informational health site
which has received unrestricted educational grants from
Medtronic plc, TCROSS NEWS, Toshiba America Medical Systems, Volcano Corporation, Terumo Medical Corporation
Cardium Therapeutics, Inc. and Lenox Hill Heart and Vascular Institute of NY

For more information, see About Us
All content, including text, photos and video
©Copyright Venture Digital LLC 1996-2021