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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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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.

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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.

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Heart pump beats current standard of care for kids awaiting transplant

August 9, 2012 by MassDevice staff

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.

Berlin Heart's Excor pediatric heart pump

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.

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HeartWare's Q2 revenues soar, losses widen

August 8, 2012 by MassDevice staff

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.

HeartWare International

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.

HeartWare closes $8M World Heart buyout

August 3, 2012 by MassDevice staff

HeartWare International closed its $8 million buyout of erstwhile rival Word Heart Corp.

HeartWare International
World Heart Corp.

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R&D expenses clip Thoratec's profits, shares slide more than 6%

August 3, 2012 by MassDevice staff

Shares of Thoratec Corp. lost more than 6% today after the medical device company said its 2nd-quarter profits were down nearly 5% on increased operating costs, largely from higher spending on research & development.

Thoratec

Thoratec (NSDQ:THOR) shares lost more than 6% yesterday after the heart pump maker said its operating costs spiked 20%, largely due to ramped-up R&D efforts, and drove a nearly 5% profit slide.

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