Defibrillator | MassDevice

FDA panel decision could boost Boston Scientific's CRM business

March 15, 2010 by MassDevice

A special Food & Drug Administration panel takes up Boston Scientific Corp.'s petition to expand indications for its CRT-Ds to larger pool of patients with heart failure, potentially providing a much-needed win for a company that's been down on its luck lately.

FDA panel decision could boost Boston Scientific

A Food & Drug Administration panel is set to decide whether Boston Scientific Corp. (NYSE:BSX) can sell its cardiac resynchronization therapy defibrillators to patients suffering from milder forms of heart failure, setting the stage for a big win for a company that's badly in need of positive news.

BSX goes before the the FDA's circulatory systems devices panel March 18 in College Park, Md., to press its case for the expanded indication. The panel will decide if the company provided enough evidence to convince regulators that the devices are effective in treating all types of heart failure.

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.

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FDA clears Medtronic's Physio-Control to resume AED sales

February 19, 2010 by MedCity News

Medtronic Inc. subsidiary Physio-Control got the nod from the Food & Drug Administration to put its automated external defibrillators back on the market after clearing up problems with its quality control procedures.

By Brandon Glenn

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MedGadget's MedTech Monday: FDA approves the world's most powerful CRT-D

February 15, 2010 by MassDevice

The Food & Drug Administration clears Sorin Group's Paradym CRT-D, which packs a 37-Joule punch; SafeStitch Medical's AMID hernia stapler gets EU clearance; Cook Medical's biologic mesh leads to reduced post-operative pain; and in emergencies, the S-SCORT S3 delivers scoop, suction, sump.

FDA approves the world's most powerful CRT-D: The Food & Drug Administration cleared Milan, Italy-based Sorin Group's next-generation cardiac resynchronization therapy defibrillator, the Paradym CRT Model 8750. It's the world's most powerful CRT-D, according to the company, packing a 37-Joule punch. The company said it's already been implanted in a first patient.

Ray Elliott puts his stamp on Boston Scientific Corp.

February 12, 2010 by Brad Perriello

Since taking over at Boston Scientific Corp., CEO Ray Elliott has made it abundantly clear that there's a new sheriff in town.

Ray Elliott puts his stamp on Boston Scientific

It's been more than seven months since Ray Elliott succeeded Jim Tobin as CEO of Boston Scientific Corp. (NYSE:BSX). In that time, and especially recently, Elliott has made it clear that things in Natick, Mass., will be different under his guidance.

And he's not taking any guff about it, either.

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St. Jude Medical wins EU nod for ICDs

February 4, 2010 by MassDevice staff

St. Jude Medical Inc. won CE Mark approval in the European Union for a pair of implantable cardiac defibrillators with what it calls the industry’s “smallest available device footprint.”

By Brandon Glenn

ST. PAUL, Minnesota — St. Jude Medical Inc. (NYSE:STJ) received European approval to begin selling two defibrillators that it says have the industry’s “smallest available device footprint.”

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Is St. Jude losing the CRM battle to Boston Scientific and Medtronic?

January 28, 2010 by MedCity News

St. Jude Medical Inc. blames lower hospital spending for a drop in sales of its pacemakers and defibrillators. There's only one problem: Its main competitors, Boston Scientific Corp. and Medtronic Inc., aren't seeing the same decline.

By Thomas Lee

LITTLE CANADA, Minnesota - It’s no secret that pacemakers and defibrillators are no longer a hot growth market. Most estimates peg global sales at growing low to mid single digits for the foreseeable future.

But for St. Jude Medical Inc, (NYSE:STJ) the question remains: How much is the company to blame for its lackluster U.S. numbers?