Category: Device News
Device specific news; Announcements, reports, reviews and device specific 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.
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:
Holliston, Mass.-based scientific instrument maker Harvard Bioscience launches a bioreactor as it looks to enter the regenerative medicine market.
When surgeons in Spain successfully replaced a young woman's trachea in 2008, using a tissue-engineered windpipe researchers had grown out of her own stem cells, the world took notice.
David Green, the president of Harvard Bioscience Inc. (NSDQ:HBIO), a Holliston, Mass.-based lab instruments maker, also noticed. Green picked up the phone to call Italy shortly after the news hit the wires; this week the company launched a commercial version of the bioreactor researchers used to grow the bronchus, the ORGANIZER Series Model 100 "In Breath" bioreactor.
The Food & Drug Administration and Health Canada both cleared a Polish reactor to supply Covidien with scarce molybdenum 99, which the Mansfield, Mass.-based company will use to make the radiological isotope technetium 99.
Covidien (NYSE:COV) won clearance from the Food & Drug Administration and its counterpart north of the border, Health Canada, to begin using a Polish nuclear reactor to supply a scarce medical isotope.
The Mansfield, Mass.-based medical products conglomerate can start using molybdenum 99 from the Polish Institute of Atomic Energy's Maria reactor to make technetium 99, which is used in imaging procedures.
Boston Scientific Corp. wins Food & Drug Administration clearance for its Express LD Iliac stent, a potential boon for its sagging peripheral interventions business.
Boston Scientific Corp. (NYSE:BSX) won pre-market approval from the Food & Drug Administration to use its Express LD Premounted stent in iliac arteries.
The expanded indication, which the company had expected during the first quarter, should help the Natick, Mass.-based device maker's sagging peripheral interventions business, which makes stents, balloon catheters, sheaths, wires and vena cava filters used to treat peripheral vascular disease.
The segment posted a 3 percent sales decrease last year, at $661 million compared to $684 million in 2008.
"We definitely see [the new indication clearance] as a boost," Boston Scientific spokesman Paul Donovan told MassDevice.
A clinical trial conducted by Medtronic of its Activa deep-brain stimulation device and epilepsy failed to meet its own goals, according to the Food & Drug Administration, which also raises safety concerns about the DBS device.
By Thomas Lee
Medtronic Inc.’s (NYSE:MDT) Activa deep-brain stimulation device failed to meet the major goals of a clinical study examining its use in treating epilepsy, according to Food & Drug Administration documents.
The Fridley, Minn.-based medical devices monolith's study of the device, which sends a trickle of electric current to the anterior nucleus region of the brain, failed to demonstrate that patients using the device experienced less seizures than patients in the control group who did not receive the therapy, according to FDA documents.
A Texas jury ruled that Smith & Nephew's Renasys-F negative-pressure wound therapy infringes a pair of patents licensed to Kinetic Concepts Inc.
A Texas jury handed a win to Kinetic Concepts Inc. (NYSE:KCI) in its wound care war with Smith & Nephew (NYSE:SNN), ruling that the British medical products conglomerate infringed a pair of KCI-licensed patents with its Renasys-F negative-pressure wound therapy.
The jury in the U.S. District Court for Western Texas decided that the Smith & Nephew product violates a pair of patents owned by Wake Forest University and licensed to KCI, which sued Smith & Nephew for patent infringement in 2008. The jury found that KCI showed it lost about $900,000 in profits and about $143,000 in lost royalties due to the infringement, which also cost Wake Forest roughly $186,000 in lost royalties, according to court documents.
