heart failure

Sunshine Heart Inc. has announced that it has received conditional approval from the FDA for an Investigational Device Exemption for its flagship C-Pulse extra-aortic, counter-pulsation, heart assist device.

Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min

US/German device company CircuLite®, Inc. has announced that it has received CE Marking approval for the Synergy® Circulatory Support System, claimed by the company to be the world’s smallest surgically implanted blood pump designed for long-term use in patients diagnosed with the condition.

When your product appears as a headline in a prominent U.S. consumer vehicle, best make hay while the sun shines. SynCardia certainly thinks so as it issues a press release about its coverage in U.S News and World Reports.

SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, has announced revenue for the quarter ended June 30, 2012, marking the company’s best quarter to date and its fifth consecutive profitable quarter.

HeartWare International Inc. has announced revenue of $29.1 million for the second quarter ended June 30, 2012, representing a 42 percent increase from $20.4 million in revenue for the same period of 2011. However the company recorded a net loss more than double prior year as it invested in R&D and commercialisation activity.

Circulatory support device company HeartWare International, Inc., has announced the closing of the acquisition of World Heart Corporation for a reported $8M in common stock, following the approval of the transaction today by World Heart stockholders.

Sunshine Heart tells us it’s come up with a device upgrade which will make its CPulse heart assist device run quieter and less bulky. The company awaits the FDA’s formal confirmation that it’s good to go, but the conditional approval has been announced. And the share price has gone up.

Sunshine Heart, Inc. has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure.

CardioKinetix Inc claims its PARACHUTE III Clinical Trial will evaluate benefits of this new therapy in a real-world setting as it commences enrollment with cases in Germany.

Results presented at EuroPCR demonstrate minimally invasive “Parachute” device from CardioKinetix could transform treatment options for patients as two year results suggest significant improvement in condition.

Heartware’s Ventricular Assist Device was expected to get the FDA Circulatory Systems Advisory Panel support, so it’s no surprise that it’s happened. FDA approval is expected to follow.

With over 10,000 implants of its life-giving heart support unit, Thoratec is right to be proud of what is one of medical device industry’s finest contributions.

Medtronic’s newly announced patient registry and heart failure studies will inform on the effectiveness of renal denervation.

CardioMEMS nurse interventions thought by FDA panel to have introduced bias to randomised trial.

A U.S.FDA panel has decided not to recommend CardioMEMS implantable heart device for treating heart failure because supporting clinical research may have been biased by human intervention.