A Medical Device Daily
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 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, the 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.
Synovis to distribute S&T instruments in U.S.
Synovis Life Technologies (St. Paul, Minnesota), a diversified medical device manufacturer, has signed a distribution agreement with S&T (Neuhausen, Switzerland), a surgical instrument manufacturer, to handle distribution of S&T's microsurgical instruments in the U.S.
Under the agreement, Synovis Micro Companies Alliance (MCA; Birmingham, Alabama), a wholly owned subsidiary of Synovis Life Technologies serving the microsurgery market, will begin selling S&T instruments immediately.
Karen Gilles Larson, president and CEO of Synovis, said the S&T line of surgical instruments is “a strong complement to Synovis MCA's product offerings, and we are excited about the opportunity to expand our microsurgical product offering.“
Markus Spingler, general manager of S&T, said, “S&T has a global reputation for producing high-quality microsurgical instruments. Synovis MCA, with its customer focus on the microsurgeon, is well positioned to distribute our product line in the U.S. market.“
Synovis MCA's foundation product is the Coupler, a device used by microsurgeons in several specialties to connect extremely small arteries or veins, without sutures, quickly, easily and with consistent results. Among S&T's products is a vessel dilator that microsurgeons employ in conjunction with the Coupler. In addition to the Coupler, Synovis MCA markets the Neurotube for repair of non-union peripheral nerves, and distributes the Varioscope head-mounted microscope.
Grifols adds U.S. plasma collection firm
Grifols (Madrid, Spain), which specializes in the production of biopharmaceuticals, has acquired PlasmaCare (Cincinnati), which specializes in plasma collection.
Grifols said the 15 dedicated plasma collection centers from PlasmaCare, located throughout the Midwest and South, would be added to the 50 plasma collection centers Grifols already operates in North America.
With this acquisition, Grifols said it would be the second-largest global supplier of plasma.
“This is a continuation of our vertical integration plan that began in 2002,“ said Victor Grifols, CEO of the Spanish company. “Securing an adequate plasma collection capacity for the foreseeable future is a critical part of meeting the demand for plasma therapies on a global scale.“
The company is a provider of plasma therapies to critically ill patients in more than 90 countries.
Marshall named to UK health post
Professor Martin Marshall has been named deputy chief medical officer at the Department of Health, effective May 15. For the past six years, Marshall has been based in Manchester, as principal in general practice at the Robert Darbishire Practice. Since 2001, he has combined this role with that of professor of general practice at the National Primary Care Research Center at the University of Manchester .
Chief Medical Officer Sir Liam Donaldson said Marshall's principal role “will be to work with me to take forward the healthcare quality and patient safety agenda with responsibility for the Healthcare Quality Directorate and professional responsibility for modernizing medical careers.“
He added: “Martin's particular expertise is the use of information about quality in primary care and engaging the public with health service delivery and performance. His experience will be invaluable as we drive this program of work forward.“