SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, developer
of the PliCath HF™ System, today announced the achievement of a significant
milestone – completion of enrollment in its pilot human clinical trial. PliCath
HF is a novel device which enables Epicardial Catheter-based Ventricular
Restoration (ECVR). The PliCath HF system is designed to treat the most common
type of heart failure (HF) by restoring a more normal geometry to an enlarged,
scarred heart. This effect is accomplished by exclusion from the left ventricle
non-contracting scar tissue, which typically results from a previous heart
attack. Numerous studies have shown that enlarged hearts not only function
poorly, but also continue to deteriorate, eventually leading to death. PliCath
HF reduces ventricular volume, thus enabling the heart to pump more efficiently
and maintain adequate perfusion to the body without excessive stress on the
muscle of the heart wall.
BioVentrix medical advisor and cardiothoracic surgeon, Dr.
Andrew Wechsler of Drexel
in the conduct of the trial and has firsthand experience with the benefits of
the technology. “The PliCath HF device enables significant LV volume reduction, resulting in restoration
of cardiac function without the risk of cutting into the heart or the need for
cardiopulmonary bypass. Most of these patients have attempted other therapies,
were extremely ill, and could not have tolerated a fully invasive surgical
approach requiring entry into the ventricle. These patients have demonstrated
impressive improvement in all categories of assessment. This product has the
potential to benefit a large number of patients with congestive heart failure.”
The 26-patient study was conducted at five leading centers
in Europe, and to date, 12 patients have
reached 90-day follow up or greater. The patients have shown an average indexed
left ventricular end systolic volume (LVESVI) reduction of 31% with a
significant improvement in ejection fraction (the percentage of cardiac volume
ejected with each heart beat). Importantly, these clinical findings were
matched by drastic improvements in the patients functional status and
quality-of-life (QOL) assessments.
HF afflicts a large population, has no cure, and is
progressively disabling. Over a million hospital admissions in the US are due to
HF, resulting in an annual cost of nearly $40 billion. An additional 670,000
new diagnoses and 250,000 HF deaths are estimated each year. Currently,
“open heart procedures” are applied sparingly among such debilitated
patients due to its invasiveness and substantial cost.
“Heart failure remains a problem of epidemic proportions,”
said Kenneth Miller, President & CEO of BioVentrix. “This device will
extend effective treatment to a large group of patients where no other option
is currently available. We are excited to move forward into our next clinical
phase, which will soon include a completely closed chest, minimally invasive
therapy for these patients.”
BioVentrix is a private corporation based in San Ramon, California.
Its mission is to improve and expand on the treatment of heart failure,
primarily through the development of less invasive approaches utilizing catheter?based
techniques. BioVentrixs Medical Advisory Board and associated physicians
include some of the worlds leading surgeons and cardiologists. For more
information about the company, please visit www.bioventrix.com.
NOTE: PliCath-HF is an investigational device and is limited
by United States
law to investigational use. For detailed product information, contact David
Schickling, BioVentrix Vice President of Sales and Marketing at (925) 830?1000.