Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral and neurovascular markets, announced the completion of patient enrollment in AAA-SHAPE, the Company’s prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
Shape Memory Medical Inc., developer of shape memory polymer devices for peripheral and neurovascular markets, announced today that its 1,500th patient has been treated, marking a significant milestone for the Company’s portfolio of shape memory polymer embolotherapy devices – The IMPEDE® Embolization Plug Family and the TrelliX® Embolic Coil.
Shape Memory Medical is delighted to announce that the IMPEDE Embolization Plug, a member of its innovative line of vascular embolization products, has won one of the 2019 R&D 100 Awards (https://www.rd100conference.com/). These awards recognize the most promising new products, processes, materials, and software developed throughout the world and introduced to the market the previous year.
Shape Memory Medical Inc. announced today it has received CE mark for its TrelliX Embolic Coil System. The TrelliX Embolic Coil System is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Indications include: Intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, arterial and venous embolizations in the peripheral vasculature. The TrelliX Embolic Coil System features proprietary shape memory polymer (SMP) technology.
Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE-FX Embolization Plug. The IMPEDE-FX Embolization Plug is an adjunct to the IMPEDE Embolization Plug which previously received 510(k) clearance by the FDA and is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX is available in three sizes, with the maximum device having an expanded diameter of 12 mm.
Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE Embolization Plug. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in three sizes, to treat vessels up to 10 mm in diameter.
Shape Memory Medical Inc. announced today the initial closing of its Series-B Preferred Stock financing. The round was led by HBM Healthcare Investments Ltd. Current investors, including affiliates of Wexford Capital LP and HBM-MedFocus Funds participated in this financing, and were joined by new investor Emergent Medical Partners.
Shape Memory Medical (formerly Shape Memory Therapeutics (SMT)) announced today the hiring of medical device industry veteran Ted Ruppel as President & CEO.