LoneStar receives CE mark for hydrogel implant for heart-failure
14 October 2014
California-based LoneStar Heart, Inc. has announced that it has
received the CE Mark for its Algisyl-LVR hydrogel implant, the
company’s lead product for the treatment of advanced heart failure.
Classified in Europe and in the US as a medical device, Algisyl-LVR
is intended to reverse progression of heart failure in people who
have an enlarged left ventricle. Surgically injected directly into
the heart muscle, the hydrogel acts immediately as an internal
scaffold that does not undergo long-term degradation and increases
Six-month outcome studies of Algisyl-LVR will be presented at the
annual meeting of the American Heart Association (AHA), November
15-19, 2014 in Chicago.
“CE Marking is a major milestone our clinicians have worked hard
to achieve,” said Frank Ahmann, LoneStar Heart’s president and chief
operating officer. “Thanks to them, patients may soon have a
revolutionary treatment to reduce the symptoms of moderate to severe
heart failure and provide improvement in their clinical status and
quality of life. To date, our safety and efficacy results are
consistently trending in the right direction, and we are looking
forward to presenting the results of our AUGMENT-HF randomized
clinical trial of Algisyl-LVR at the upcoming AHA meeting in
The AUGMENT-HF randomized clinical trial is being conducted at 14
centers in Italy, Germany, Romania, Australia, and The Netherlands
to determine if the product is superior to standard medical therapy
in the management of patients with a dilated and weakened left
ventricle and significantly deteriorated cardiac function.
As reported last November 2013 at the American Heart Association
annual meeting in Dallas, interim results of the study showed left
ventricle augmentation of the failing heart after implantation with
Algisyl-LVR can be performed safely in patients with advanced heart
failure and provides functional improvement in their health status.
Extensive preclinical studies have shown Algisyl-LVR decreases
cardiac wall tension, while it improves heart muscle contractility
and oxygen uptake, leading to a decrease in ventricle stress and to
a marked cardiomechanic improvement.
About advanced heart failure
Advanced Heart Failure represents a significant and growing
epidemic healthcare burden in all developed countries. Of the more
than 12 million patients affected in the North America and in
Western Europe, about a third have significant limitations of
physical activity while half die of heart failure within five years
of diagnosis. A wide number of patients whose heart muscle is
initially damaged by infarcts, hypertension, valve disease, or other
processes lose the ability to pump blood efficiently to the body. To
overcome the initial damage, the heart muscle works under increased
stress without an opportunity to recover. Eventually, the muscle of
the left ventricle begins to stretch out and the muscle cells lose
the ability to contract normally. The therapeutic options for many
of these patients who do not respond to drug and device therapies
are limited and can be extremely complex and costly.
Source: LoneStar Heart Inc press release.