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Bio2 Medical announced the Angel® Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA). This 510(k) clearance includes a first ever, prophylactic indication for a medical device to protect critically ill patients at high-risk for pulmonary embolism (PE) and contraindicated for anticoagulation.
Dr. Luis F. Angel, the inventor of the Angel® Catheter and Chief Medical Officer at Bio2 Medical, provided the following comment regarding the importance of Bio2 Medical’s participation in the FDA’s Early Feasibility Pilot Study Program: “The Early Feasibility Pilot Program was a great opportunity to formally introduce this device to the FDA and to understand their requirements and our vision for this product. It also provided us the possibility to evaluate this device in the United States in a research environment that is proven to be the most effective and scientifically sound. In the end, this process was very beneficial to introducing a new device with a new indication and also for the FDA in learning about future products early in their life cycle.”
The Angel® Catheter provides a novel alternative to IVC filters for PE protection in a vast patient population that has historically been underserved. The Angel® Catheter features a temporary Inferior Vena Cava (IVC) filter that is permanently attached to a Central Venous Catheter (CVC), and has been designed to reduce the rates of PE-related morbidity and mortality by trapping clinically significant pulmonary emboli. The Angel® Catheter is now commercially available in the U.S.
Christopher E. Banas, Chairman and Chief Executive Officer of Bio2 Medical, stated, “We are excited to enter into this new commercial phase and to have the opportunity to fulfill our company’s mission to improve patient outcomes by offering our life-saving product to the American public. The transition to a successful and profitable company is fully underway with the hiring and training of a national direct sales team, led by Jeffrey Hutchison, our new Vice President of U.S. Sales. The achievement of U.S. FDA 510(k) clearance represents the successful culmination of a significant undertaking for Bio2 Medical, and we could not have done it without the faith, trust and support of our entire team, our Board of Directors and our investors who have tirelessly supported our dream and made this day possible.”
For Further Information
More on the central venous catheter market can be found in a series of reports published by iData Research entitled the US Market Report Suite for Vascular Access Devices and Accessories. The suite covers market reports on implantable ports, port needles, central venous catheters, peripherally inserted central catheters, peripheral intravenous catheters, dialysis catheters, ultrasound vascular access device and accessories, syringes and needles.
The iData report series on vascular access devices covers the United States, Japan, South Korea, Australia, India, China, Brazil and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, competitor SWOT analyses, disease overviews, product pipelines, press releases, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more on vascular access device and accessories market data or procedure data, register online or email us at [email protected] for a US Market Report Suite for Vascular Access Devices and Accessories brochure and synopsis.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
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About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.
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