Category: Cardiac Assist DevicesSyndicate content

Medicare panel meeting highlights concerns about gaps in LVAD research

November 30, 2012 by MassDevice staff

A November panel meeting at the Centers for Medicare & Medicaid Services highlights the agency's concerns about gap in evidentiary research supporting ventricular assist devices.

Centers for Medicare and Medicaid Services logo

At a meeting of the Centers for Medicare & Medicaid Services surveyed members agreed almost universally that there are clinically significant gaps in research regarding ventricular assist devices.

The panelists gathered earlier this month to review coverage decision for VADs, which is currently provided for heart failure patients after open-heart surgery, as a bridge to heart transplant and as a destination therapy.

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Breaking: HeartWare wins FDA nod for bridge-to-transplant heart pump

November 20, 2012 by MassDevice staff

HeartWare wins premarket approval for its flagship implantable left ventricular assist device as a bridge to transplant for heart failure patients.

HeartWare International logo

Framingham, Mass.-based cardiac device maker HeartWare International (NSDQ:HTWR) won FDA premarket approval for its HeartWare ventricular assist system as a bridge to heart transplantation.

The HeartWare system includes an implantable pump, external driver and power source that can be used either inside or outside of hospitals, the FDA noted.

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FDA slaps HeartSine with Class I recall

November 20, 2012 by MassDevice staff

HeartSine's recall of Samaritan defibrillators gets Class I status from the FDA over concerns that battery defects could lead to patient injury or death.

HeartSine logo

The FDA gave HeartSine's Samaritan defibrillator recall Class I status over concerns that battery issues could lead to patient injury or death.

The Samaritan 300/300P public access defibrillators, which were found to intermittently turn off and on, may be unable to deliver therapy during a cardiac event due to the battery defects.

Shareholders sue Abiomed over Impella claims

November 19, 2012 by MassDevice staff

Shareholders of medical device company Abiomed filed a purported class action lawsuit, accusing the company of inflating its stock price with rosy predictions for its flagship Impella 2.5 heart pump.

Abiomed

Shareholders of Abiomed (NSDQ:ABMD) filed a lawsuit seeking class action status, accusing the medical device company of inflating its share price with falsely rosy predictions for its flagship Impella 2.5 heart pump.

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Abiomed wins FDA nod for Impella trial

November 15, 2012 by MassDevice staff

Abiomed wins FDA approval for an investigational device exemption trial of its Impella RP heart pump for right-side percutaneous cardiac assistance.

Abiomed

Abiomed (NSDQ:ABMD) said it's won a nod from the FDA to run a clinical trial of its new heart pump for right-side cardiac assistance, the Impella RP.

Abiomed retrenches on Medicare rate nod

November 2, 2012 by MassDevice staff

Abiomed shares regain some value on news of new reimbursement codes from Medicare for its Impella heart pump.

Abiomed

Abiomed (NSDQ:ABMD) said the Centers for Medicare & Medicaid Services approved a trio of reimbursement codes for its Impella heart pumps, allowing ABMD shares to regain some of the roughly 30% investors pared from the stock this week.

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CardioKinetix lands CE Mark for its full suite of Parachute heart implant sizes

October 25, 2012 by MassDevice staff

California-based medical device company CardioKinetix wins CE Mark approval for all 8 sizes of its Parachute ventricular partitioning device, designed to provide percutaneous ventricular restoration therapy.

CardioKinetix Parachute

California-based medical device company CardioKinetix landed CE Mark approval in the European Union for the full suite of its Parachute ventricular partitioning devices, including 8 sizes of the device designed to provide support to weakened heart muscles. .