Medical Devices Today

Warning Letters Drop 24% In 2006; FDA Weighs Additional 'Corporate' Letters

From the March 2007 issue of "The Silver Sheet"

The volume of FDA quality system warning letters fell 24 percent in 2006, but not necessarily because the device industry has become more cognizant of Quality System Regulation requirements, FDA acknowledges. Rather, limited agency resources and a high investigator turnover rate could be to blame, officials say.

Edwards Set To Launch "Two-Trials-In-One" For Sapien Percutaneous Valve

From the March 26, 2007, issue of "The Gray Sheet"

Edwards Lifesciences will soon begin a 600-patient U.S. pivotal clinical trial for its Sapien transcatheter aortic replacement heart valve at Columbia University Medical Center and the Cleveland Clinic, the company says.

Announced March 20, FDA clearance allows the company to enroll the first 40 patients at up to eight centers in the PARTNER trial (Placement of AoRTic traNscathetER valves). Edwards plans to expand the trial to 15 additional sites, pending FDA clearance.

U.S. Device Industry Tries To Take Active Role In Fashioning India's Regs

From the March 19, 2007, issue of "The Gray Sheet"

U.S. device industry stakeholders are planning formal talks with India's government about the creation of a regulatory body dedicated to medical devices.

Imports constitute 75% of India's $1.5 billion medical device market, projected to grow at a 12%-16% rate up to 2010, according to Pacific Bridge Medical, a consulting firm focusing on Asian markets for medical products. Many U.S. companies already operate in India, and all of them have to deal with the difficult reality that the majority of medical devices are defined and regulated as drugs.

It's The Economy, Stupid: "Value" Campaign To Stress System-Wide Savings

From the March 19, 2007, issue of "The Gray Sheet"

AdvaMed will invest $2 million in 2007 to accelerate its public campaign to underscore the "value" of medical technology to patients, practitioners and policymakers, placing added emphasis on the long-term cost savings devices provide to the U.S. economy.

The association plans to renew and expand a Washington, D.C.-based advertising campaign initiated last year and develop a series of white papers reporting socioeconomic analyses.

For InSightec, CMS Holds Ticket To Treating Fibroids In Younger Women

From the March 19, 2007, issue of "The Gray Sheet"

The lack of third-party reimbursement has hindered sales of InSightec's ExAblate 2000 uterine fibroid treatment, but the firm is hopeful that recent recommendations from CMS' advisory panel for hospital outpatient payments will help the unique treatment gain traction.

"The CMS payment level is really critical to providing access to this technology, and it's really what is holding back widespread adoption," InSightec Director of Marketing Lynn Golumbic told "The Gray Sheet."

FDA Previews New Drug-Eluting-Stent Guidance At CRT Meeting In D.C.

From the March 12, 2007, issue of "The Gray Sheet"

FDA's upcoming drug-eluting-stent guidance will emphasize long-term safety and shift the focus of trials from surrogate to clinical endpoints.

Interventional Cardiology Review branch chief Ashley Boam and CDRH reviewer Andrew Farb explained FDA's vision for the new guidance at the Cardiovascular Research Institute's Cardiovascular Revascularization Therapies meeting in Washington, D.C., March 7.

MDUFMA Reauthorization Agreement Is In Place - AdvaMed

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

The medical device industry has reached an agreement with FDA on what will be included in updated user fee legislation, according to AdvaMed President Steve Ubl.

The pact "accomplishes three important things," Ubl said at a Feb. 27 press briefing. "We have made significant improvements in [FDA's] performance [goals], we will significantly reduce application fees and we will change the mechanism such that the year-over-year increases in fees will be much more predictable than they were in the first go-around."