A Medical Device Daily
Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, reported receiving CE-mark approval for its MitraClip system.
The company says that the MitraClip is the first commercially available device which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).
Percutaneous mitral repair with the MitraClip device is performed by interventional cardiologists in the catheterization laboratory. The heart beats normally during the procedure, and a heart-lung bypass machine is not required.
Saying that MR is the most common type of heart valve insufficiency in the U.S. and the second most common in Europe, Evlve added that the vast majority of patients are untreated. "[That] leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder and ultimately leading to heart failure," the company said.
Evalve said that CE-mark approval will allow it to train and educate physicians in Europe on the use of the MitraClip device, increasing the number of patients who will potentially benefit from the treatment.
The company said it would work with hospitals across Europe to establish training programs to allow physicians to gain access to this new technology.
In addition to CE-mark approval, Evalve reported completing enrollment in the high-risk registry arm of the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) in North America.
"Patients who are high-risk surgical candidates may benefit from a less-invasive procedure," the company said, adding that EVEREST investigators are collecting follow-up data to assess the risk/benefit profile from the less-invasive MitraClip procedure.
The company said that EVEREST investigators from more than 40 sites across North America have reached additional milestones in the ongoing Phase II study, having treated more than 300 patients with nearly 400 MitraClip devices implanted.
Evalve said trial data "continues to grow, with a significant amount of three-year follow-up results available as well as four-year data from some patients."
"The progress we have made, notably the milestones achieved in the EVEREST trial and receiving CE-mark approval, are important as we move toward commercialization in Europe and the U.S.," said Ferolyn Powell, president/CEO. "We believe the MitraClip system has the potential to benefit patients who currently suffer from the serious effects of MR. [It] offers the patients a new alternative" to surgical treatment.
Evalve is the first portfolio company from The Foundry (Menlo Park), a medical device incubator.
Czech, please for Live Tissue Connect
Technology management company CSMG Technologies (Corpus Christi, Texas) said that its Live Tissue Connect (LTC) subsidiary's technology will be presented at the Central European Congress of Surgery in Prague, Czech Republic, next month.
Dr. Robert Tucker, MD, PhD, of the University of Iowa (Iowa City), has had three clinical papers peer-reviewed and accepted at a surgical congress. Tucker will be presenting the three papers, which describe his results with Live Tissue Connect's technology and product performance, at the congress, set for April 23-26.
Donald Robbins, president/CEO of CSMG, said, "It is a ... privilege for LTC to have Dr. Tucker's papers selected for presentation at the CECS Congress. This our first opportunity to publicly unveil the RF sealing results that are obtainable with LTC's products, and to compare such to leading RF sealing medical device companies that already have a market presence."
CSMG owns the technology and exclusive world rights to the live-tissue bonding device through LTC, a subsidiary formed for the development and exploitation of the platform technology. The CE mark has been received on the electrosurgical generator, and FDA 510(k) documentation has been filed for the duct and vessel-sealing product.
Surgeons at 27 Ukrainian hospitals and clinics are using the tissue welding/bonding technology in clinical trials. They have completed more than 10,000 human surgeries, including more than 80 types of open and laparoscopic procedures, establishing that the technology is universal in its ability to repair soft biological tissue.
UK, France distribution agreement
WaferGen Biosystems (Fremont, California), a developer of gene expression, genotyping, cell biology and stem cell research systems, reported the signing of an exclusive distribution agreement for the company's SmartSlide Micro-Incubation System with Labtech International in the UK and Labtech France in France.
The distributor agreement covers WaferGen's entire family of SmartSlide Micro-Incubation System products.
Labtech International is a provider of scientific products to researchers in the life science markets in the UK, while its sister company, Labtech France, coordinates distribution of the same products in that country.
WaferGen's SmartSlide Micro-Incubation System is a first-of-its-kind family of integrated fluidics exchange micro-incubation products that work seamlessly with inverted microscopes. The technology is enabling cell biology and stem cell researchers to conduct complex time-lapse imaging studies to characterize, differentiate and proliferate cells, as well as grow stem, primary and other difficult-to-cultivate cells in consistently optimal physiological conditions.
Danish firm eyes Minnesota facility
International biotech firm Genmab (Copenhagen, Denmark) said it has signed an agreement to buy a manufacturing facility in Brooklyn Park, Minnesota, currently owned by PDL Biopharma.
The $240 million transaction is subject to customary closing conditions, including clearance by U.S. antitrust authorities.
All 170 employees currently working at the 215,000-square-foot facility received offer letters from Genmab, contingent on successful closing of the purchase.
Genmab develops human antibody therapeutics for unmet medical needs. Diseases targeted by its products include leukemias, lymphomas, rheumatoid arthritis, and head and neck cancer. Its antibodies also have potential for treatment of many other diseases.
The company reports having 10 products in clinical testing and three in late-stage clinical trials.