Research News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Myocor: FDA has conditionally approved Myocor's plan for a feasibility study of its iCoapsys minimally invasive mitral valve repair system, the firm announced Dec. 4. The single-arm Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) study will evaluate the device in patients with mitral valve insufficiency caused by left ventricular dysfunction and coronary artery disease. iCoapsys is a high-strength cord, anchored by pads on the outside of the heart, which stretches across the left ventricle to pull the sides of the ventricle together and decrease the distance between the mitral valve leaflets. The device can be delivered with interventional catheters through the pericardium. It is the surgically implanted version of the Coapsys that Myocor is evaluating in the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve (RESTOR-MV) trial. RESTOR-MV compares Coapsys to annuloplasty repair in patients undergoing coronary artery bypass surgery who also have functional mitral regurgitation (1"The Gray Sheet" Jan. 3, 2005, p. 17)
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Financings In Brief
Remon Medical Technologies: Waltham, Mass. concern announces close of oversubscribed $26 mil. Series C financing, which will help expand U.S. presence of its wireless, intra-body communication technology for use in therapeutic products. First-time investors in the financing round include Guidant, Triathlon Medical Ventures and Medica Venture Partners. Guidant previously incorporated Remon's interactive sensor technology into its Ancure abdominal aortic aneurysm endograft (1"The Gray Sheet" Feb. 18, 2002, In Brief). Other major Remon financiers include Polaris Venture Partners, Concord Ventures, Lilly Ventures, KBL Healthcare Ventures and Ofer Hi-Tech. The privately held firm intends to commercialize its communication technology through a mixture of internal efforts and external strategic collaborations. Remon is now conducting clinical trials of its Impressure device, which offers an on-demand, non-invasive way to monitor intra-aneurysm pressures after endograft procedures. The firm's HeartLook device for measuring pulmonary artery pressure is also under investigation...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
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