A Medical Device Daily Staff Report
Sunshine Heart (Eden Prairie, Minnesota) reported a collaboration with Minnetronix (St. Paul, Minnesota) for a transcutaneous energy transfer (TET) system to power the company's fully-implantable C-Pulse device under development.
Minnetronix specializes in med-device engineering, providing design and manufacturing support for medtech companies.
A TET system enables power transfer across the skin without direct electrical connectivity utilizing time varying magnetic fields. TET is used to power implanted devices, such as heart assist devices, artificial hearts and electrical stimulators. The agreement leverages Minnetronix's existing TET technology and includes milestone payments due to Minnetronix prior to U.S. regulatory approval for the fully-implantable C-Pulse system.
"We are pleased to have entered into our second partnership with Minnetronix," said Dave Rosa, CEO of Sunshine Heart. "Currently, they are the supplier of our second generation C-Pulse driver and we have been pleased with the quality, responsiveness and service they have provided. We look forward to closely partnering with them for our TET system for our fully implantable C-Pulse system."
Sunshine Heart initiated its COUNTER HF U.S. pivotal trial for its C-Pulse system earlier this year. The company intends to initiate animal studies for its fully-implantable pump in the fourth quarter of this year. The C-Pulse device is also in an ongoing OPTIONS HF European post-market study.
The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the U.S., Canada and countries that do not recognize the CE mark approval, uses the scientific principles of intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility trial, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their condition as a result of the therapy.
In other agreements/contracts news:
• Nano Labs (Detroit) has signed a non-disclosure agreement (NDA) with GMI of Mexico.
GMI says its interest in Nano Labs' nano coatings (NC2012) products lie in the areas of insulating fire retardant, waterproof protection, and the proprietary anti-graffiti, self-cleaning paint.
Concurrent to GMI's review and testing of the products, the companies are working together to establish a joint venture agreement which would outline the strategic commercialization of these product lines. The joint venture would be designed to drive sales for both companies allowing Nano labs to leverage GMI's existing infrastructure, clientele, and distribution network.
GMI is a Mexican consortium with companies that for more than 50 years has worked together and established themselves as a leading provider of building technology, products and services. With modern industrial equipment and machinery and the latest technology, GMI applies the most advanced production processes, achieving productivity and quality of the highest levels.
NC2012 is an insulating paint coating nanotechnology highlighted by its very low thermal conductivity. NC2012 reduces transmission of temperatures through the coated elements. Nano Labs is a nanotechnology research and development company. Agilent Technologies and SomaLogic Enter Agreement to Expand Access to Cutting-Edge Proteomic Technology
• Agilent Technologies (Santa Clara, California) and SomaLogic (Boulder, Colorado) reported that they have entered into an agreement to expand access to SomaLogic's unbiased protein biomarker discovery platform.
The companies will initially place SomaLogic's SOMAscan proteomic assay, which uses custom Agilent microarrays in its workflow, in select academic and contract research centers. Although the SOMAscan assay is already available to researchers directly from SomaLogic as a service, this planned roll-out is aimed at meeting the rapidly growing demand for access to SomaLogic's highly multiplexed, cost-effective proteomic analyses.
"This agreement will greatly enhance our current microarray offerings by expanding them into the rapidly growing proteomics market," said Jacob Thaysen, VP/GM of Agilent's Genomics Solutions Division. "SomaLogic's cutting-edge proteomic technology makes them an ideal partner for us to increase our presence in this growing market."
SomaLogic is a privately held biomarker discovery and clinical diagnostics company. Agilent Technologies is a measurement company and a technology specialist in chemical analysis, life sciences, diagnostics, electronics, and communications.
• The Premier (Charlotte, North Carolina) healthcare alliance has awarded new agreements for drug eluting coronary stents, non-drug eluting coronary stents and diagnostic and interventional cardiology products.
Suppliers being awarded for drug eluting coronary stents, non-drug eluting coronary stents and diagnostic and interventional cardiology products include: Abbott Laboratories, Abbott Vascular Division (Alpharetta, Georgia); Boston Scientific (Natick, Massachusetts); and Medtronic (Minneapolis).
Suppliers being awarded for diagnostic and interventional cardiology products include: Arrow International (Reading Pennsylvania); Johnson & Johnson Health Care Systems (Piscataway, New Jersey); Merit Medical Systems (South Jordan, Utah); Oscor (Palm Harbor, Florida); and St. Jude Medical (Saint Paul, Minnesota).
Premier operates a purchasing network and maintains clinical, financial and outcomes databases.