Leading heart pump maker
HeartWare International
(
HTWR
) recently revealed that it has strengthened its HeartWare
Ventricular Assist System portfolio in Europe with the CE Mark
extension for long-term use in patients susceptible to fatal heart
failure. The company has also published the U.S. clinical results
of ADVANCE, an Investigational Device Exemption ("IDE") study,
designed to test the system as a bridge to heart transplantation
for advanced heart failure patients.
The expanded CE Mark label followed the success of the
international trial, which resulted in high survival rates of
critically ill patients and also the extended usage of ventricular
assist devices ("VAD") in Europe.
The results of the U.S. ADVANCE Bridge-to-Transplant ("BTT")
trial, published in the American Heart Association's journal
Circulation, reported positive patient outcomes of 140 candidates
who were treated with the HeartWare investigational device. It was
observed that survival rates and quality of life improved at 180
day following the treatment. Some of the risks associated with the
system include infection, bleeding, perioperative right heart
failure and stroke.
The HeartWare Ventricular Assist System comprises a small blood
pump called HVAD pump, surgical tools and patient accessories,
which help a patient's weak heart to pump blood from the left
ventricle into the aorta. About 2,000 HeartWare Ventricular Assist
Systems have been implanted in patients globally. The device was
cleared in the European Union in 2009 and in Australia in March
2011. Recently, the company revealed 50 clinical sites in the U.S.
along with 91 customer sites in 25 nations.
Currently, the HeartWare Ventricular Assist System is not
available commercially in the U.S.. The device is the subject of
clinical trials in the U.S. for two indications, namely, BTT under
continuous access protocol and destination therapy ("DT").
HeartWare submitted a Pre-Market Approval ("PMA") application with
the U.S. Food and Drug Administration ("FDA") for the BTT
indication in December 2010. The PMA includes data from the ADVANCE
trial.
FDA's Circulatory System Devices Advisory Committee, in April
2012, announced that the advantages of using the HeartWare
Ventricular Assist System outweigh the risks associated with
it.
HeartWare makes miniaturized implantable heart pumps, also known
as ventricular assist devices, which are used for the treatment of
patients at a risk of advanced heart failure. The company competes
in the heart devices market with
Thoratec Corporation
(
THOR
) among others.
HEARTWARE INTL (HTWR): Free Stock Analysis
Report
THORATEC CORP (THOR): Free Stock Analysis
Report
To read this article on Zacks.com click here.
Zacks Investment
Research