Category: Cardiac Assist DevicesSyndicate content

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. .  

Abiomed touts positive results for its Symphony heart pump

October 24, 2012 by MassDevice staff

Abiomed unveils clinical updates on its Symphony device following the 2nd successful human use in Canada, showing positive results over 28 days.

Abiomed logo

Massachusetts medical device company Abiomed (NSDQ:ABMD)  reported positive clinical results for the 1st Canadian patients implanted with the company's Symphony device, a minimally invasive pump designed to slow the progression of heart failure and help the heart remodel.

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Abiomed: Medicare coverage decision unlikely for Impella | Wall Street Beat

September 26, 2012 by MassDevice staff

Medical device company Abiomed says the chances are slim that Medicare will grant a national coverage decision for its Impella heart pump.

MassDevice.com Wall Street Beat

Abiomed (NSDQ:ABMD) said it doesn't believe that the Centers for Medicare & Medicaid Services is likely to bestow a national coverage decision for its Impella heart pump.

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