Category: Cardiovascular

NMT names eight to advisory board

March 11, 2010 by MassDevice staff

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.

Feds demand Medtronic docs in false claims investigation

March 11, 2010 by MassDevice staff

It's shaping up to be a tough day for Medtronic Inc. (NYSE:MDT), as news of a federal false claims investigation follows questions from the Food & Drug Administration about a study of one of its deep-brain stimulation devices.

The Fridley, Minn.-based medical devices monolith revealed in a March 10 securities filing that the U.S. Attorney for Massachusetts issued a "civil investigative demand" Feb. 22 for documents in a false claims probe into the relationship of its CoreValve subsidiary with the Burlington, Mass.-based Lahey Clinic, "specifically relating to cardiologists at the clinic, CoreValve Inc. ... and the Lahey Clinic, and certain employees of both [Medtronic] and the clinic, among other topics."

FDA flags Guidewire on sterilization issues

March 10, 2010 by MassDevice staff

The Food & Drug Administration warned a Salem, N.H.-based maker of guidewires used in catheters that its quality systems aren't up to snuff.

Regulators made public March 10 a warning letter sent to Guidewire Technologies Inc., advising the company that they are in violation of three quality systems regulations that must be remedied.

The agency said in a Feb. 26 letter that the company is failing to test each production run to ensure the products have been sterilized and that the company's Teflon guidewire coating process has not been validated. In addition, the agency said internal quality systems haven't been audited since 2006.

Aastrom Biosciences winds up treatment stage of Phase 2 clinical trial

March 9, 2010 by MedCity News

By Brandon Glenn

Aastrom Biosciences Inc. (NSDQ:ASTMD) finished treating patients in a Phase 2 clinical trial of its cardiac-repair stem cells.

The milestone clears the way for Aastrom to report six-month interim results of the trial later this year, according to a press release.

In the trial, Aastrom treated 40 patients suffering from dilated cardiomyopathy, a severe form of congestive heart failure in which the heart becomes weakened and enlarged and cannot pump blood efficiently.

HeartWare's trial milestone triggers executive payouts

March 8, 2010 by MassDevice staff

Another milestone, another payday for executives at HeartWare International Inc. (NSDQ:HTWR) — although the taxman needed to take his cut too.

When the 140th, and final, patient enrolled in HeartWare's "bridge-to-transplant" trial late last month, the event triggered financial windfalls for top management at the Framingham, Mass.-based firm. Under performance rights plans adopted by the HeartWare board in 2007 and 2008, executives received restricted stock awards worth between $100,000 and nearly $1.3 million, depending on their position on the corporate ladder. But the awards also created sizable tax liabilities for the seven individuals, prompting them in recent days to sell off a portion of their holdings to cover the cost of taxes on their newfound wealth.

Boston Scientific files cross-appeal in stent patents suit against Johnson & Johnson

March 5, 2010 by MassDevice staff

Boston Scientific Corp. (NYSE:BSX) may have won the most recent round in its stent patents war with Johnson & Johnson (NYSE:JNJ), but that didn't stop the Natick, Mass.-based devices giant from cross-appealing a Delaware judge's ruling.

The patents in question are at the heart of complicated legal wrangling involving Boston Scientific, its New Brunswick, N.J.-based rival and competitor/partner Abbott (NYSE:ABT). The dispute centers around Boston Scientific's Promus stent, a private-label version of Abbott's Xience V stent, and the JNJ subsidiary Cordis Corp.'s Cypher.

Aastrom Biosciences back in NASDAQ's good graces

March 5, 2010 by MassDevice staff

By Brandon Glenn

ANN ARBOR, Mich. – Aastrom Biosciences (NSDQ:ASTMD), once in danger of being de-listed from the NASDAQ exchange, regained compliance with the exchange’s $1 minimum-share-price requirement.