Medical Device Industry News

FDA panel narrowly clears Medtronic DBS device

March 15, 2010 by MassDevice staff

A special panel convened by the Food & Drug Administration narrowly cleared Medtronic's Activa DBS deep-brain stimulation device for treating epilepsy, despite concerns over its efficacy and safety.

By Thomas Lee

A Food & Drug Administration panel narrowly approved a deep brain stimulation device developed by Medtronic Inc. (NYSE:MDT) to treat epilepsy.

The panel voted 7-5 to green-light the Activa DBS, which uses electricity to stimulate the anterior nucleus region of the brain. The panel’s findings are not binding on the FDA, but the agency almost always follows the recommendations of such bodies.

Caliper settles 14-month patent spat with Shimazdu

March 15, 2010 by MassDevice staff

Hopkinton, Mass.-based lab equipment and services provider Caliper Life Sciences reaches a settlement with Shimadzu Scientific Instruments Inc. over its electrophoresis system.

Caliper Life Sciences, Inc. (Nasdaq: CALP) says that Shimazdu Scientific Instruments, Inc. has agreed to remove one of its DNA and RNA sequencers from the U.S. market after the company's settled a 14-month patent dispute.

The Hopkinton, Mass.-based lab equipment and services provider had alleged that Shimazu's MCE-202 MultiNA microchip electrophoresis system infringed on 11 different U.S. patents held by Caliper. The MultiNA is a microchip electrophoresis system the company says can quickly and easily perform DNA and RNA nucleic acid size confirmation and quantitation in life science research.

Boston Scientific holds ICD, CRT shipments on FDA snafu

March 15, 2010 by MassDevice staff

Boston Scientific Corp.'s stock dips on news that it's holding all shipment of its implantable cardiac defibrillators and cardiac resynchronization therapy devices, after discovering it missed filings with the Food & Drug Administration.

Boston Scientific Corp. (NYSE:BSX) is holding all shipments of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulling all inventory from the field after discovering that it missed a pair of filings with the Food & Drug Administration.

The medical device-making giant said it failed to notify the FDA of two changes to its manufacturing process for its Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality ICDs and CRT-Ds. The changes were "successfully validated" and there is no risk to patient safety, according to a press release. Boston Scientific's pacemakers and other products are not affected by the move.

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.