Medical Devices Today

Renal Stenting Surprise: CMS Proposes To Keep Coverage Status Quo

This article is reprinted from "The Gray Sheet" – November 26, 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

CMS' proposal to maintain its existing renal stenting coverage policy surprises many stakeholders who expected the agency to further restrict coverage because the data on the intervention's effectiveness is relatively weak.

The agency strongly encourages enrollment in randomized clinical trials to resolve "general uncertainty" about whether stenting offers any benefits or risks over other treatment options, but it stops short of making trial enrollment a condition of coverage in the Nov. 20 ¹proposed coverage policy.

For at least the past decade, percutaneous transluminal angioplasty of the renal arteries has been nationally covered as an alternative to surgery in patients who have not responded to drug therapy. Coverage of renal artery stenting is at the discretion of local Medicare contractors.

With ICD Leads Under Scrutiny, FDA Expects To Update Guidance In 2008

This article is reprinted from "The Gray Sheet" – November 19, 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

FDA plans to release new PMA guidelines for pacemaker and implantable defibrillator leads in 2008 to give manufacturers more guidance on bench testing.

"We're bringing the document up to what companies are doing already, which is a larger battery of tests," Megan Moynahan, chief of CDRH's Pacing, Defibrillator and Leads review branch told "The Gray Sheet."

The 2008 guidance document, developed over the last several years, addresses premarket development of pacemaker leads, but will also be a "a good jumping off point" for ICD leads, Moynahan says. The products are under increasing scrutiny in the medical community following last month's recall of Medtronic's 7-French diameter Sprint Fidelis lead and reports of similar concerns with St. Jude Medical's competing thin ICD lead.

Riegel v. Medtronic At Supreme Court: Common Law Against Federal Statute

This article is reprinted from "The Gray Sheet" – November 12, 2007

A major case impacting the medical device industry's vulnerability to product liability suits will land in the U.S. Supreme Court next month and legal scholars predict the outcome will be a close call.

Riegel v. Medtronic will be argued in Washington, D.C., Dec. 4 following the plaintiff's appeal of a 2006 federal appeals ruling that Medtronic is not liable for injuries to a patient that resulted when one of the company's catheters burst during the course of a procedure (see chart: "¹Case Background").

Medtronic's victory was in large part due to the appeals court's support of the federal pre-emption defense - that FDA's premarket approval of the device design and its labeling protects the company from lawsuits in state courts.

"Body Computing" On The Web: An Interview With Cardiologist Leslie Saxon

This Special Bonus Interview is from the November 5, 2007, issue of "The Gray Sheet"

Leslie Saxon says the next big thing in medicine is "body computing."

As the chief of cardiovascular medicine at the University of Southern California's medical school describes it, body computing relies on devices with sensors that transmit information to the Web to be accessed and acted upon not only by doctors but by patients as well.

Medical devices with remote monitoring capabilities (see ¹previous story), already available from firms including Medtronic, St. Jude Medical, Boston Scientific and MedApps in the cardiac rhythm management and diabetes spaces, will be central, though not sufficient to achieve this model, she says.

U.S. Officials, Industry See Border Delays In Impending China Import Reg

From the November 5, 2007, issue of "The Gray Sheet"

U.S. officials with the World Trade Organization and the U.S. device industry are challenging China's government on pending regulations they say will create unnecessary delays in getting devices into China and onto its market.

Decree 95, or Administrative Measures on Examination and Supervision of Imported Medical Devices, was issued by Chinese authorities this summer and is scheduled to take effect Dec. 1.

The measure, which would give substantial new border authority to China's Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ), comes amid growing concerns among the Chinese public about safety of domestic and imported devices.