BioVentrix Completes Enrollment in Pilot Human Clinical Trial of the PliCath HFâ„¢ Heart Failure Treatment System
BioVentrix medical advisor and cardiothoracic surgeon, Dr. Andrew Wechsler of Drexel University, participated 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.