Medical Devices Today

OrbusNeich Says "Bio-Engineered" Stent May Be Solution To Thrombosis Risk

From the May 28, 2007, issue of "The Gray Sheet"

OrbusNeich hopes to lead a new wave of stent technology with its Genous Bio-engineered R-Stent, which the firm says is safer than existing drug-eluting stents because it has a natural antibody coating instead of a drug-eluting polymer.

David Camp, OrbusNeich's VP-strategic marketing and business development, spoke to "The Gray Sheet" about the device's potential May 23 from Barcelona, host of the EuroPCR conference May 22-25.

Genous was CE marked in August 2005 and is being evaluated in a number of studies in Europe. The Hong Kong firm met with FDA in March to discuss a pivotal trial to support U.S. approval of the device.

Poor Supplier Control Causing Recalls, FDA Says; Contract Is Key To Success

From the May 2007 issue of "The Silver Sheet"

FDA is stressing the importance of complying with supplier controls in an effort to stem the rising number of recalls associated with vendor-provided products.

“We as an industry have to start focusing in on this,” Kim Trautman, FDA GMP/quality systems expert, told “The Silver Sheet.” As industry has “become more globalized,” she says, “it has started to outsource a lot more things. In doing so, it has now started to stretch its controls of those suppliers thinner and thinner.”

Trautman and other FDA officials are speaking at industry conferences and workshops to highlight vendor issues and remind companies of their responsibility to abide by the purchasing controls section of the Quality System Regulation.

Postmarket User Fees Floated At House Subcommittee Hearing

From the May 21, 2007, issue of "The Gray Sheet"

The chairman of the House subcommittee overseeing reauthorization of medical device user fees is signaling that he might push to have a portion of industry-provided funds specifically allocated for FDA postmarket activities.

"Postmarket surveillance issues ... are equally as important" to achieving expedited premarket review, House Energy and Commerce Subcommittee on Health Chairman Frank Pallone, Jr., D-N.J., said during a May 16 hearing.

Under the Medical Device User Fee & Modernization Act, enacted in 2002 and set to expire Sept. 30, FDA collects fees from device manufacturers submitting applications for marketing approval. The fees are expressly intended to help FDA speed up the premarket review process.

Industry Dissatisfied With Senate-Approved Pediatric Device Provisions

From the May 14, 2007, issue of "The Gray Sheet"

Device industry lobbyists are seeking changes to provisions in the Senate user fee reauthorization bill relating to medical devices for children.

Approved by the Senate May 9, the FDA Revitalization Act (S 1082) covers a broad range of FDA issues, including the reauthorization of the Medical Device User Fee & Modernization Act, which is strongly supported by the device industry.

The bill's pediatric device provisions, derived from legislation introduced in March by Sen. Christopher Dodd, D-Conn., seeks to encourage the development of devices for children and adolescents and ensure sufficient regulatory oversight of the products.

CMS Backs Away From Expanding Carotid Stenting Coverage

From the May 7, 2007, issue of "The Gray Sheet"

CMS has reversed its earlier proposal to significantly expand coverage of carotid stenting, dampening industry's hopes for a more open U.S. carotid stent market in the near term.

The April 30 decision essentially maintains a 2005 policy that covers carotid stenting in patients for whom the "gold standard" endarterectomy surgery is too risky and who have symptomatic blockage >70% in their neck arteries. CMS covers high-risk symptomatic patients with between 50% and 70% blockage and asymptomatic patients with >80% blockage only in FDA-approved studies.

Following a March 2006 request from Guidant to more closely align Medicare coverage with the devices' FDA indications, in February CMS proposed to extend unrestricted carotid stenting coverage to high-risk, asymptomatic patients with blockage >80%. That policy would have doubled the population covered for the procedure, according to industry.

Advisory Panel Recommends Approval For Link's STAR Ankle Replacement

From the April 30, 2007, issue of "The Gray Sheet"

An FDA advisory panel recommended approval of Link Orthopedics' STAR ankle replacement system April 24 despite FDA reviewers' conclusion that results of the firm's pivotal trial are unclear.

The Orthopaedic & Rehabilitation Devices panel voted 4-2 in favor of Link's PMA for the Scandinavian Total Ankle Replacement (STAR) system at a meeting in Gaithersburg, Md.

STAR is the first nonconstrained mobile bearing total ankle system to be reviewed by the agency. It is intended as an alternative to fusion (arthrodesis) surgery to replace an ankle joint deformed by rheumatoid arthritis, primary arthritis or posttraumatic arthritis, according to the indication requested in Link's PMA.