Category: Cardiac Assist DevicesSyndicate content

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.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

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.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

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.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Meeting: Will CMS limit off-label use of left ventricular assist devices?

September 7, 2012 by MassDevice staff

There may be good news for Thoratec and bad news for HeartWare if the Centers for Medicare & Medicaid Services decide at their upcoming meeting to limit off-label use of left ventricular assist devices.

The Centers for Medicare & Medicaid Services logo

The Centers for Medicare & Medicaid Services are likely to leave current payment intact for left ventricular assist devices, but an agenda released ahead of a November meeting hints at possible restrictions on off-label use for the costly devices.

The federal agency plans to meet November 14 to review available evidence on LVADs and discuss how best to optimize outcomes for heart failure patients, especially when it comes to pinpointing which patients are likely to benefit from the procedure.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

CircuLite, NeuroSigma land CE Marks

September 5, 2012 by MassDevice staff

CircuLite won CE Mark approval in the European Union for its Synergy heart pump; EuroZone regulators also OK NeuroSigma's Monarch trigeminal nerve stimulation device for epilepsy and depression.

CE Mark

The European Union granted CE Mark approval to a pair of medical device companies, CircuLite and NeuroSigma, for their technologies designed to treat heart failure, epilepsy and depression.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp