Category: Cardiac Assist Devices
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.
Berlin Heart's Excor heart pump helps children with heart failure survive longer while awaiting a heart transplant, but risks of infection and other serious side effects remain high, according to a new study.
Children with heart failure survived longer while awaiting a heart transplant when they received therapy with Berlin Heart's Excor pediatric ventricular assist device than when treated with the current standard of care, according to a new study.
The Excor PAD device was not without risks, but survival rates for children on the device were "significantly higher" than those in the control group, according to the study's authors.
Wall Street shrugs off a 126% increase in net losses for HeartWare on the strength of a 43% top-line gain; share gain slightly on The Street.
Even though 2nd-quarter net losses soared for HeartWare International (NSDQ:HTWR), sales rose 43% for the medical device company, sending shares up a tick today.
HeartWare, which makes implantable heart pumps, reported losses of $22.8 million, or $1.61 per share, on sales of $29.1 million during the 3 months ended June 30.