Life Sciences Newsbriefs: Week of December 13, 2010

Author:Ms Melissa Gilmore
Profession:McGuireWoods LLP
 
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CONTENTS:

Medical Devices Drugs & Biologics Food & Dietary Tobacco Medical Devices

Federal jury rules in favor of VNUS in patent dispute Total Vein Solutions and Biolitec have been ordered to pay $46 million in damages to VNUS Medical Technologies, a Covidien unit, after a San Francisco-based federal jury found that they infringed on a patent held by VNUS for a laser-based technique used in varicose vein treatment. The jury, however, also nullified some of VNUS' claims related to a patent for an endovenous laser ablation procedure. TVS CEO David Centanni said the company "is confident that those findings of the jury that were in error will be overturned, either by the trial court or at the appellate level."

FDA clears Tomophase imaging system Tomophase has received FDA 510(k) clearance for its Optical Coherence Tomography Imaging System, which will initially be used to view airways and lung tissue. The company will eventually make the device available for therapeutic applications.

FDA warns OsteoSymbionics over manufacturing violations The FDA has issued a warning letter to cranial implant developer OsteoSymbionics alleging manufacturing violations, including failure to set up processes guaranteeing that standards for product design are met. "Most of the issues have been addressed and corrected, and those that haven't will be taken care of in the first quarter," said the company's CEO, Cynthia Brogan.

Senators call on FDA to "proceed cautiously" with 510(k) changes Minnesota Democratic Sens. Amy Klobuchar and Al Franken joined 13 other senators to call on the FDA to exercise more caution before implementing proposed changes to the 510(k) process. In a letter to FDA Commissioner Dr. Margaret Hamburg, the bipartisan group said the agency "should carefully consider the impact of any proposed change on the ability of companies to innovate in a predictable and consistent regulatory environment so they can continue to bring medical advances to patients." The letter comes as the agency prepares to issue its recommendations on changes to the process.

Penumbra initiates recall of catheter for stroke patients The FDA said Penumbra has pulled from the market a lot of its Penumbra System Reperfusion Catheter 032 after finding that a manufacturing problem may cause mid-shaft joint failures, which could lead to death or serious injury. The agency classified the recall as Class I.

Medtronic unit's valve replacement device gets approval in Europe Medtronic's CoreValve division has secured CE Mark approval for its a valve-replacement system that can treat severe aortic stenosis without requiring patients to undergo open-heart surgery. Medtronic paid $700 million to purchase CoreValve in 2009.

House panel chairman sees waste in some medical procedures Rep. Darrell Issa, R-Calif., slated to head the House's chief investigative panel, said this week that he supports the idea of factoring cost-effectiveness into Medicare coverage decisions, but only if doctors -- not government officials -- lead the decision-making processes. "[M]edical panels of people who care about what's best for their patients ... is good science and good medicine," he said.

U.S. attorney investigates Medtronic's marketing of brain stimulators A U.S. attorney in New York issued a subpoena to Medtronic seeking information about its marketing and reimbursement of implantable brain stimulation devices. The company said in a regulatory filing that it is cooperating, and later added that it had "no comment beyond what we state in the filing."

Exactech to pay $3M to resolve kickback allegations Exactech has agreed to pay $3 million to settle allegations that it paid kickbacks to surgeons to use its joint replacement devices. The company also has signed a deferred prosecution deal with the U.S. attorney's office in New Jersey, ending the investigation. "We are pleased to resolve this inquiry, which we feel is in the best interest of our stakeholders," said Bill Petty, Exactech chairman and CEO.

FDA clears Orthovita's bone graft substitute Orthovita has received FDA clearance for its bone graft substitute, Viotoss Bioactive Foam-2X. The product, which is expected to be available by late February or early March, has been cleared for use as a bone void filler in the pelvis, extremities and spine.

Hanger Orthopedic, Aastrom Biosciences go public Aastrom Biosciences has filed for an initial public offering of 10 million shares in order to raise as much as $20.5 million that will be used for corporate-related purposes. Meanwhile, Ares Corporate Opportunities Fund, a major shareholder in Hanger Orthopedic Group, has put up for sale 2 million Hanger shares at $20 each.

Sources: Beckman Coulter mulls possible sale Sources say Beckman Coulter has sought assistance from Goldman Sachs to consider various strategic options, including a potential sale of the diagnostic test developer. Beckman would have the right to decline a possible sale if it believes the offer isn't adequate, the sources said.

BG Medicine to launch IPO In a regulatory filing, BG Medicine said it plans to publicly offer 4.7 million shares next week in order to secure as much as $71.2 million, according to Renaissance Capital. The company, which makes biomarker-based tests, plans to use the proceeds to support the launch of its BGM Galectin-3 diagnostic test and submit possible regulatory applications, among other purposes.

ArthroCare gets approval for debridement device in Europe EU regulators have granted CE Mark approval to ArthroCare's WoundWand...

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