Medical Device Industry News

Medtronic launches clinical trial of CoreValve heart valve replacement system

March 12, 2010 by MedCity News

Medtronic Inc. launches a 1,000-patient study of its CoreValve aortic stenosis therapy, designed as a minimally invasive method of replacing faulty heart valves.

By Brandon Glenn

Medtronic Inc. (NYSE:MDT) launched what’s expected to be a 1,000-patient study of a catheter-based system it hopes will become a less-invasive — and highly lucrative — alternative to open-heart surgery for valve replacement.

Medtronic’s CoreValve system allows a replacement heart valve to be placed in a patient’s body via a catheter inserted in the femoral artery, near the groin. A catheter is a thin, flexible tube that can be inserted into a body cavity to open a passageway or to allow fluids to pass through.

OMNIlife inks distribution deal with French artificial hip maker

March 12, 2010 by MassDevice staff

Taunton, Mass.-based OMNIlife Science Inc. will be the exclusive distributor of hip articulation technology made by Societe d'Etudes Recherches Fabrication-Dedienne Sante.

OMNIlife Science Inc. will be the exclusive U.S. distributor of articulation technology used in artificial hips made by a French maker of orthopedic and dental implants.

Taunton, Mass.-based OMNIlife said the deal with Societe d'Etudes Recherches Fabrication-Dedienne Sante will begin as soon as the company receives regulatory approval from the Food & Drug Administration. Further terms of the deal were not announced.

FDA warns on fake surgical mesh

March 12, 2010 by MassDevice staff

The Food & Drug Administration issues a warning to healthcare providers about counterfeit surgical mesh products that ape C.R. Bard's Davol brand.

The Food & Drug Administration is warning healthcare providers to be on the lookout for fake surgical mesh products that ape C.R. Bard's (NYSE:BCR) Davol Inc. brand, saying hospitals and surgical centers — not to mention patients with surgical mesh implants — should be especially vigilant.

The federal watchdog agency said four sizes of the counterfeit flat sheet polypropylene surgical mesh have been pegged by the FDA and Bard so far:

Medtronic registers $3 billion debt offering

March 12, 2010 by MassDevice staff

Minneapolis-based medical device monolith Medtronic registers for a $3 billion offering of its senior debt notes to drum up cash for working capital and perhaps to pay down debt.

Medtronic Inc. (NYSE:MDT) registered with the Securities & Exchange Commission for a $3 billion offering of senior debt notes in a bid to raise funds to cover its working capital needs and, perhaps, to pay down some of its debt.

The Fridley, Minn.-based medical device monolith announced the offering of $1.25 billion worth of its 3 percent senior notes, due in 2015; $1.25 billion of its 4.45 percent senior notes due in 2020; and $500 million of its 5.55 percent senior notes due in 2040.

NxStage locks in $15 million credit line from Silicon Valley Bank

March 12, 2010 by MassDevice staff

Lawrence, Mass.-based portable dialysis maker NxStage Medical Inc. says the deal gives it some flexibility to "seize future opportunities when they arise" and amends some of the terms of a loan from Japanese distributor Asahi.

NxStage Medical Inc. (NSDQ:NXTM) took advantage of favorable interest rates to lock up some more working capital, possibly for future acquisitions.

The Lawrence, Mass.-based portable dialysis maker said it has secured a two-year revolving line of credit for $15 million with Silicon Valley Bank at an interest rate of about 6 percent annually.

NxStage said it would use the debt to "finance working capital needs as the business continues to grow and to seize future opportunities, when they arise," CFO Robert Brown, said in prepared remarks.

Breeden's Robert Fields quietly steps down from Steris board

March 11, 2010 by MedCity News

Robert Fields, partner and managing director at Breeden Capital Management and Breeden Partners, quietly resigned from Steris Corp.'s board for personal reasons March 5.

By Mary Vanac

Robert Fields, a partner and managing director at Breeden Capital Management and Breeden Partners, quietly resigned from the Steris Corp. (NYSE:STE) board for personal reasons March 5.

Normally, the resignation of a director causes few questions. However, Fields and Richard Breeden, the former Securities and Exchange Commission chief who has since become an investment manager and shareholder activist, are a special case.

NMT names eight to advisory board

March 11, 2010 by MassDevice staff

Boston, Mass.-based NMT Medical beefs up its science chops as it prepares for Closure 1 trial data analysis.

NMT Medical Inc. (NSDQ:NMTI) named a group of physicians and scientists from leading hospitals and research institutions to shore up its scientific advisory board in anticipation of the data analysis portion of a clinical trial of the company's StarFlex implant.

The Boston, Mass.-based device company, which is developing implants to treat structural heart disease through catheter-based procedures, named eight to the board, which it says will advise executives on issues related to its ongoing Closure 1 clinical trial.