Medical Devices Today

Device Firms Go Direct To Consumers Amid Physician Skepticism

This article is reprinted from "The Gray Sheet" – December 17, 2007

Device firms are increasing investments in television advertising for their implantable products, but some physicians are skeptical that safety information about complex devices can be adequately conveyed in direct-to-consumer ads.

A television ad campaign for Johnson & Johnson/Cordis' Cypher sirolimus-eluting stent was launched on Thanksgiving Day, the first effort to market a stent directly to patients in that medium.

"Drug-eluting stents are complex devices that offer tremendous patient benefits, but also carry certain risks," commented Gregg W. Stone, an interventional cardiologist with Columbia University Medical Center and vice chairman of the Cardiovascular Research Foundation. "This complex message has been difficult to accurately communicate through traditional media, especially given our constantly evolving understanding as new studies emerge."

IRB Reform Is Low-Hanging Fruit For FDA-Duke Clinical Trial Initiative

This article is reprinted from "The Gray Sheet" – December 10, 2007

One of the first jobs for a new FDA/Duke University partnership aimed at modernizing clinical trials will be reforming policies for institutional review boards so studies can get off the ground more quickly, participants say.

The public/private partnership will bring together government agencies, industry, and the medical and academic communities to identify strategies to make the research process more efficient and develop new standards and technologies to improve safety and enhance the quality of clinical trial data.

An important focus of the initiative, unveiled Nov. 26, will be to trim the fat off the U.S. clinical research process so larger studies can be completed more quickly and with less expense, explained Robert Califf, M.D., vice chancellor for clinical research at Duke University and co-chair of the partnership.

R&D Tax-Credit Extension Goes Down To The Wire

This article is reprinted from "The Gray Sheet" – December 10, 2007

Device lobbyists are joining a year-end push for an extension of a soon-to-expire tax credit for companies engaged in research and development, but opportunities are running out.

Continue reading this article on FDA Legislative Watch.

This article is reprinted from "The Gray Sheet" – December 10, 2007

Device lobbyists are joining a year-end push for an extension of a soon-to-expire tax credit for companies engaged in research and development, but opportunities are running out.

Continue reading this article on FDA Legislative Watch.

Four Firms Apply For Medicare New-Tech Add-On Payments

This article is reprinted from "The Gray Sheet" – December 3, 2007

“The Gray Sheet” – Comprehensive news and analysis for medical device professionals. Click here for a free, 30-day trial. © FDC Reports 2007 - All Rights Reserved

Four manufacturers are seeking new-technology payments for their devices in the fiscal year 2009 inpatient payment rule, despite industry's frustration with CMS' process for granting the add-on payments.

FzioMed (Oxiplex intra-operative gel), TherOx (Downstream SuperSaturatedOxygen system), Emphasys Medical (Zephyr endobronchial valve) and SynCardia Systems (CardioWest temporary total artificial heart) met the Nov. 19 application deadline for special payments for new services or technologies under the Acute Care Hospital Inpatient Prospective Payment System.

The four applications are the most CMS has received in three years. The number of applicants for the payments had declined steadily from 10 for FY 2005, to eight for 2006, three for 2007 and one for 2008.