A Medical Device Daily
WorldHeart (Oakland, California), a maker of mechanical circulatory support systems, said it has received regulatory authorization from the Greek Ministry of Health to proceed with a feasibility clinical trial of its rotary ventricular assist device (VAD) in human subjects at St. Luke's Hospital (Thessaloniki, Greece).
The trial is expected to begin imminently, pending completion of the final elements of preclinical verification and validation procedures.
WorldHeart said its rotary VAD will be the only bearingless, fully magnetically levitated centrifugal rotary pump in clinical trials. The VAD is a next-generation, continuous-flow pump that uses magnetic levitation to fully suspend the spinning impeller, its only moving part, inside a compact housing.
The pump's levitation technology uses a combination of passive magnetic suspension and single-axis active control, which the company said is expected to provide “optimal system simplicity and reliability.“
WorldHeart said that, relative to pumps with blood or mechanical bearings, full magnetic levitation eliminates wear mechanisms within the pump “and is expected to provide improved blood compatibility by allowing greater clearances and more favorable, obstruction-free, blood flow around the impeller.“
The study protocol was approved by the Ethics Committee at St. Luke's Hospital last November, and a team of cardiac surgeons and perfusionists from that institution completed technical and clinical training last week in Salt Lake City. That training was conducted at WorldHeart's Rotary Systems operation, the University of Utah and LDS Hospital.
Antonis Pitsis, MD, cardiac surgeon and director of the Thessaloniki Heart Institute at St. Luke's and principal clinical investigator of the feasibility trial, said, “Our surgical team is now ready to conduct the clinical trial for this well-designed rotary VAD. We are looking forward to using the WorldHeart rotary system to provide circulatory support to a select group of patients.“
Petros Sfirakis, MD, deputy director of cardiac surgery at the Onassis Cardiac Surgery Center (Athens, Greece), also participated in the training. The Onassis Cardiac Surgery Center has experience with WorldHeart's CE-marked Novacor pulsatile VAD and will collaborate with St. Luke's in the initial clinical trial of the WorldHeart rotary VAD.
Jal Jassawalla, president and CEO of WorldHeart, said, “We are pleased with the progress made in the preclinical development of our advanced rotary system, and that readiness for its evaluation in the European feasibility trial is on schedule.“
He said that integration of the company's Rotary Systems operations, acquired last year from MedQuest Products, “has proceeded rapidly,“ adding that with the rotary VAD and the next-generation pulsatile Novacor II system, “we believe we will have the broadest platform of next-generation 'assist' and 'replacement' systems under development to meet the long-term needs of patients across a wide spectrum of heart failure conditions.“
Liberté gets reimbursement OK in France
Boston Scientific (Natick, Massachusetts) said it has received reimbursement approval from the French government for its Taxus Liberté paclitaxel-eluting coronary stent system, the company's next-generation drug-eluting stent system.
The approval was published earlier this week in the official journal of the French government, Journal Officiel de la Republique Francaise.
As a result of the reimbursement approval, the Taxus Liberté stent system now will be available to patients treated in both private and public hospitals throughout France.
Dr. Philippe Brunel, interventional cardiologist at the Nouvelles Cliniques Nantaises (Nantes, France), said, “The Taxus Liberté stent system offers cardiologists and patients benefits due to its superior deliverability in addition to the proven long-term efficacy of the Taxus system. Patients with complex and small-vessel disease will particularly benefit from these advanced features.“
Jeff Goodman, president of Boston Scientific's International business, said, “The Taxus Liberté stent system is designed to improve deliverability and conformability for . . . stent performance, which will help further improve clinical outcomes.“
The company said the Taxus Liberté system is the world's first next-generation DES system to incorporate a next-generation stent platform. It is specifically designed for drug delivery and received CE-mark approval last September.
Boston Sci said more than 165,000 stents are implanted annually in private and public French hospitals, half of them drug-eluting stents.
ABS gets EU okay for knee implant
Orthopedic implant maker Advanced Bio-Surfaces (ABS; Minneapolis) said it has been notified that its technical file for the OrthoGlide Medial Knee Implant fulfills the requirements of the European Union's (EU) Medical Device Directive. The notification from the company's Notified Body, TUV Product Services (Munich), allows Advanced Bio-Surfaces to immediately begin applying the CE mark to the implant for sale in the EU.
The company said the cobalt-chrome alloy composition of the OrthoGlide implant has successfully passed functional and safety requirements, and added that its design “provides positional stability without the use of rigid fixation methods.“
Advanced Bio-Surfaces said the OrthoGlide has a contoured geometry that functions to provide an open glide path and allows for the unconstrained motion of the femoral condyle, while requiring less tissue and bone removal than current surgical options.
Dr. Jeff Felt, chairman and CEO, said the receipt of the CE mark enables the company to offer the OrthoGlide implant “to more patients in need of a better option for osteoarthritis.“
The OrthoGlide Medial Knee Implant is ABS's first product.