MicroMed Cardiovascular (Houston), which is focused on the development of miniaturized implantable ventricular assist technology, said it has initiated a multicenter evaluation of its newest design of the DeBakey VAD (ventricular assist device).
The European studies originally carried out to achieve the CE mark for commercial distribution of the device were based on the initial design of the DeBakey VAD. The company said it believes further evaluation would be beneficial to illustrate the technology’s advancement from the initial design, as well as MicroMed’s “ongoing commitment to mechanical assist technology.”
MicroMed said it has aligned itself with eight European centers to evaluate the latest refinements to the DeBakey VAD technology.
Under the guidance of Dr. Georg Wieselthaler, director of mechanical circulatory support and heart transplant at Vienna General Hospital and the Medical University of Vienna (both Vienna, Austria) and principal investigator of this study, up to 40 patients will be implanted in the postmarket evaluation. “We look forward to this important clinical study to evaluate the performance of MicroMed’s latest series device,” Wieselthaler said.
The DeBakey VAD system has been awarded the CE mark for bridge to transplant and destination therapy in Europe. The DeBakey VAD Child also been awarded the CE mark for commercial distribution in Europe, along with FDA approval. More than 370 adult and pediatric devices have been implanted worldwide, totaling more than 88 patient years of experience.
The company said the miniaturized DeBakey VAD represents the next generation of implantable mechanical ventricular support for advanced heart failure. It said the design addresses limitations of first-generation systems such as weight, size, noise, reliability and high rates of infection.
The newest VAD’s small size – about the size of a “C” battery, measuring only 1” x 3” and weighing 4 ounces – eliminates the need for abdominal surgery associated with current-generation devices, MicroMed said.
The DeBakey VAD heart pump is the result of research by the National Aeronautics and Space Administration, in collaboration with the Baylor College of Medicine (also Houston) and MicroMed.
MicroMed has said it believes that the DeBakey VAD represents “an important therapeutic option” for the global population of about 15 million persons suffering from heart failure, given that only about 2,000 donor hearts suitable for transplantation become available each year in the U.S. and about 4,000 worldwide.
Named for Dr. Michael DeBakey, noted heart surgeon who with Dr. George Noon was involved in its design, the DeBakey VAD is intended for adult and pediatric advanced heart failure patients who no longer can provide necessary blood flow with their native heart. The device is designed to take over virtually all left ventricular function and concurrently monitor real-time flow parameters.
MicroMed has two ongoing clinical investigations in U.S. heart transplant centers to evaluate the safety and effectiveness of the DeBakey VAD for use as a bridge to heart transplantation and for destination therapy for patients ineligible for heart transplant.
Nine-month results on R stent reported
Nine-month clinical follow-up results of the HEALING II study involving the Genous R stent from OrbusNeich (Fort Lauderdale, Florida/Hong Kong) were presented at the 15th annual Singapore Live congress by Robbert de Winter, MD, PhD, director of the catheterization laboratory at Academic Medical Center (Amsterdam, the Netherlands).
The objective of the 10-center, 63-patient study is to demonstrate the safety and stent-related healing response to the Genous stent, which received the CE mark last August.
In a statement, the company noted that the Achilles’ heel of stenting, restenosis, has been “significantly reduced” with drug-eluting stents (DES), but that restenosis has been supplanted by stent thrombosis due to “purposely delayed” healing.
OrbusNeich said such stents require long-term, dual-antiplatelet therapy, “which if discontinued prematurely may result in stent thrombosis, with its inherent high mortality rate.”
The company said its Genous device is the first stent designed to accelerate the natural healing response by capturing a patient’s own endothelial progenitor cells (EPCs) from the bloodstream. “Once captured, EPCs rapidly form a protective endothelial layer over the stent, providing protection against thrombus and minimizing restenosis,” it said.
de Winter said the nine-month study results demonstrated a clinically driven target lesion revascularization (TLR) rate of 6.3% and a major adverse cardiac events (MACE) rate of 7.9%. No sub-acute or late thrombosis was reported despite the protocol recommendation of only one month of dual-antiplatelet therapy.
“Tellingly, there were no additional events since the six-month angiographic follow-up, indicating that the healing process was stabilized,” he said.
OrbusNeich sells medical devices for vascular disease in more than 60 countries through sales offices in 10 countries, manufacturing operations in the Netherlands and China, and research and development facilities in the U.S. Its product portfolio includes the R stent, the Avita PTCA dilatation catheter and the SafeCut dual-wire dilatation catheter.
Micrus gets approvals in Europe, Japan
Micrus Endovascular (San Jose, California) said it has received the CE mark for its Pharos stent, which will allow the company to begin marketing the stent for the treatment of ischemic and hemorrhagic stroke. Micrus said it expects to immediately begin selling the Pharos stent in the European Union and all countries recognizing the CE mark, through its direct sales and distribution network.
The Pharos stent was developed and will be brought to market under an agreement between Micrus Endovascular and Biotronik (Berlin, Germany) reported in January.
John Kilcoyne, president and CEO of Micrus, said the introduction of the Pharos stent “provides our customers with a new tool to treat both ischemic and hemorrhagic stroke.” He said the stent is “the first of several products we plan to jointly develop and market using Biotronik’s technology.”
Claus Martini, CEO of Biotronic, said the approval of the companies’ first collaborative product “is a testament to our synergistic relationship with Micrus Endovascular. We are delighted to see our technology move beyond the cardiovascular and peripheral vascular intervention markets, and look forward to introducing additional products through our collaboration.”
Micrus also has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan to market its system for the endovascular treatment of cerebral aneurysms in that country. The approval includes the MicruSphere, HeliPaq and InterPaq embolic coils.
Micrus said it believes that Japan represents a “significant portion” of the total Asian market that is estimated to produce about one-third of interventional cerebral vascular disease procedure revenues worldwide.
“Entry into the Japanese coiling market represents a significant revenue opportunity for [us],” said Kilcoyne. “We expect to benefit from the continued growth in conversions from the highly invasive craniotomy and clipping procedure, which is currently performed on greater than 75% of aneurysms treated in Japan, to the minimally invasive coiling procedure.” The company’s distribution and service partner in Japan is Goodman Co. Ltd.
“Our growth strategy includes further expansion into the Asian market,” Kilcoyne said. “We are working with Goodman to obtain approval in Japan for the balance of our product portfolio, including our bioactive Cerecyte products, as well as our UltiPaq coils, catheters and guidewires.” He added that the company is seeking approval in the first half of this year to enter the Chinese market with a majority of its product line.
‘Limited trial’ seen for CardioPass in Europe
CardioTech International (Wilmington, Massachusetts) said its European Notified Body has requested to that company acquire additional clinical data to support its submission for CE mark approval of the CardioPass artificial coronary artery graft for use with “no option” patients.
In response to that request, CardioTech said it is in the process of planning a limited clinical trial in Europe. The company plans to expand the initial indication for use of the CardioPass graft from just “no option” patients to patients who present with suboptimal (diseased or inferior) vessels discovered while undergoing surgery.
CardioTech said it believes that up to 15% of the 600,000 patients who undergo bypass surgery worldwide each year have suboptimal vessels. The company said the expanded indications would allow surgeons to determine during a bypass operation if the patient has the required native vessels of sufficient quality to complete the revascularization.
Currently, when a surgeon is unable to identify such native vessels during the time that a patient can “reasonably” be kept on bypass, the surgeon is often forced to complete the operation utilizing suboptimal vessels, CardioTech said.
It said the clinical availability of the CardioPass graft would offer the surgeon the ability to choose during the procedure to utilize the CardioPass to complete the needed revascularization.
Michael Szycher, PhD, chairman and CEO, said, “We regard this response by the notified body as an important, positive milestone to obtaining marketing approval in Europe for the CardioPass graft.”
Edwards breaks ground in Shanghai
Edwards Lifesciences (Irvine, California), which focuses on heart valve technologies, reported breaking ground for its new heart valve manufacturing facility in Changi North, Singapore. The manufacturing facility, scheduled for completion in October 2007, will be Edwards’ third global manufacturing facility dedicated to producing its Carpentier-Edwards Perimount replacement tissue heart valves.
Construction of the 98,000-square-foot facility will begin immediately and is expected to employ up to 500 when operating at full capacity. In the interim, Edwards will continue to operate in a temporary facility in Kaki Bukit, Singapore.