Category: Cardiac Assist Devices
The FDA gives CardiacAssist Investigational Device Exemption approval for a pivotal clinical study of the TandemHeart circulatory support system.
Pittsburgh-based medical device maker CardiacAssist received Investigational Device Exemption approval from the FDA to begin a pivotal clinical study of its TandemHeart circulatory support system.
The TandemHeart to Reduce Infarct Size trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients with severe heart attack, according to the press release.
Abiomed's dilemma is of its own making, Jefferies & Co. analyst Raj Denhoy tells MassDevice.com.
UPDATED Dec. 14, 2012, at 10:30 a.m.
Abiomed (NSDQ:ABMD) is impaled on the prongs of a 3-horned dilemma with its flagship Impella heart pump, and it's a problem of its own making, according to 1 Wall Street analyst.
Thoratec receives approval from Japan's Ministry of Health, Labor & Welfare to launch its HeartMate II, which provides a "bridge-to-transplantation therapy" for patients with advanced heart failure.
Medical device maker Thoratec (NSDQ:THOR) said the company won Japan's Ministry of Health, Labor and Welfare approval for its HeartMate II, a device designed to help the heart's pumping action in patients with severe heart disease and for use in people waiting for a heart transplant.
An FDA advisory panel's decision to maintain Class III status on certain cardiovascular assistance devices means Abiomed and other device makers must re-apply for FDA approval.
An FDA panel decision will require some cardiovascular pump makers to submit their already-approved medical devices for review under the FDA's more stringent premarket review pathway.
The federal watchdog agency's Circulatory Devices Advisory panel this week acknowledged that non-roller-type cardiopulmonary bypass blood pumps are life-supporting, but recommended against shifting them to a lower-risk category for temporary ventricular support. Panelists also suggested down-classification into Class II (special controls) for cardiopulmonary and circulatory bypass therapy.
The FDA's Circulatory System Devices Panel votes to keep Abiomed's Impella heart pump at a Class III risk level, meaning the devices will continue to pass through the premarket review process.
Abiomed (NSDQ:ABMD) shares slid 7% on Wall Street after the Danvers, Mass.-based cardiac devices maker lost a bid to have its star Impella heart pumps shifted to a lower FDA review risk category.
A November panel meeting at the Centers for Medicare & Medicaid Services highlights the agency's concerns about gap in evidentiary research supporting ventricular assist devices.
At a meeting of the Centers for Medicare & Medicaid Services surveyed members agreed almost universally that there are clinically significant gaps in research regarding ventricular assist devices.
The panelists gathered earlier this month to review coverage decision for VADs, which is currently provided for heart failure patients after open-heart surgery, as a bridge to heart transplant and as a destination therapy.
HeartWare wins premarket approval for its flagship implantable left ventricular assist device as a bridge to transplant for heart failure patients.
Framingham, Mass.-based cardiac device maker HeartWare International (NSDQ:HTWR) won FDA premarket approval for its HeartWare ventricular assist system as a bridge to heart transplantation.
The HeartWare system includes an implantable pump, external driver and power source that can be used either inside or outside of hospitals, the FDA noted.