CoreValve (Paris) will begin a European Phase I clinical trial of its ReValving System at The Heart Center (Seigburg, Germany), having received institutional review board (IRB) approval at that institution. The trial calls for use of the ReValving System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery. The principal investigator will be Eberhard Grube, MD, chief of cardiology at The Heart Center.
Jacques Seguin, MD, PhD, chairman, CEO and founder of CoreValve, said, "Obtaining IRB approval in Germany represents a significant milestone in establishing ReValving as the next-generation cath lab therapy for interventional cardiology, as early inclusion of European investigative centers will fast-forward adoption of [our] technology." Seguin said the company's ongoing clinical trial in Asia "already has successfully demonstrated that ReValving is feasible to non-surgically treat the widest possible range of patients, including traditional surgical-candidates," adding that the European trial will involve high-surgical-risk patients.
"While CoreValve clearly focuses on the core of the market – that is, traditional surgical-candidates -– we also will respond to cardiologists' requests to treat high-surgical-risk cases, a definitive sub-segment of the percutaneous aortic valve replacement market," Seguin said. He said the company expects that such treatments "will accelerate physicians' adoption of ReValving." He added that additional compassionate-use trials will be initiated in different European countries. Seguin said the results of the company's feasibility cases "allow us to confidently – and ahead of schedule – drive our Phase I clinical trial to a successful conclusion as soon as possible."
CoreValve's delivery system is based on a catheter and self-expanding stent approach on a beating heart, thus avoiding open-heart surgery. The ReValving procedure can be performed in a cardiac cath lab, just like angioplasty and stenting, with less trauma to the patient and, according to the company, "substantial cost savings to the healthcare system."
Three centers buy Abiomed device
Abiomed (Danvers, Massachusetts) said the first European orders for its AB5000 Circulatory Support System have been placed by Herzzentrum Nordrhein-Westfalen (Bad Oeynhausen, Germany), Azienda Ospedaliera Niguarda Ca'Granda (Milan, Italy) and University Hospital Lund (Lund, Sweden). The sales follow the Abiomed's announcement during its most recent quarterly investor call that it had launched a plan to expand its business internationally.
The AB5000 provides temporary support for one or both sides of the natural heart in circumstances where the heart has failed, giving the heart the opportunity to rest and potentially recover - and, the company said, "giving surgeons the therapeutic flexibility necessary to determine the best endpoint for treatment."
Michael Minogue, CEO and president, said, "We are committed to making these systems available globally and offering patients worldwide the possibility of recovering after a serious cardiac event, and returning home with their natural hearts, untethered by permanent devices."
Dr. Rainer Korfer at Herzzentrum Nordrhein-Westfalen, said, "By making this system available to allow patients' hearts to rest and potentially recover following a cardiac event, we will be giving them a greatly improved chance of survival."
The AB5000 Circulatory Support System consists of two primary components. The AB5000 Ventricle is a disposable blood pump capable of supporting the left, right or both ventricles of the heart, while the AB5000 Console is a software-driven system that drives the blood pumps and can be used either in the hospital or for transport of patients between hospitals. The AB5000 is based on technology developed for the AbioCor Implantable Replacement Heart.
New driver for artificial heart
SynCardia Systems (Tucson, Arizona), a developer of biomechanical cardiac replacement and mechanical circulatory support devices, has licensed a new smaller driver for its CardioWest Total Artificial Heart (TAH) from Medos Medizintechnik AG (Stolberg, Germany). Medos is a developer of driver systems and ventricular assist devices and other circulatory support devices. The new driver, a console that pulses pressurized air and monitors pump function, is a fraction of the size of the original driver used for the TAH. SynCardia said it would allow patients greater mobility, leading to a speedier recovery and improved patient spirits.
Studies are being conducted with the TAH outside of the U.S. to be able to transition the patient to recovery at home. The company said its technology would eventually be a stepping-stone to discharge of patients while awaiting transplantation. "Licensure of the driver is a key element in our overall plan toward greater mobility and eventually portability," said SynCardia President and CEO Marvin Slepian, MD. "This driver represents an intermediate step toward our goal of a smaller, more portable driver, which will enable patients to leave the hospital while awaiting a heart transplant."
Hans Peter Inger, CEO of Medos, said, "Our driver technology [has] been used with ventricular assist devices and ... this [collaboration] opens the door to many new uses of that technology."
Since 1994, the paracorporal Medos Ventricular Assist Device System has been used in almost 600 cases worldwide.