Category: Cardiac Assist Devices
Abiomed wins FDA approval for an investigational device exemption trial of its Impella RP heart pump for right-side percutaneous cardiac assistance.
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 shares regain some value on news of new reimbursement codes from Medicare for its Impella heart pump.
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.
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.
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 unveils clinical updates on its Symphony device following the 2nd successful human use in Canada, showing positive results over 28 days.
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.
Medical device company Abiomed says the chances are slim that Medicare will grant a national coverage decision for its Impella heart pump.
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.
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 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.
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.
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.