Tag: Shape Memory

Shape Memory Medical Announces European Enrollment in the AAA-SHAPE Randomized Controlled Pivotal Trial

SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first enrollment in Europe in the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) […]

Shape Memory Medical Announces Publication of Study Results in Vascular

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the publication of results from the Company’s prospective, open-label, single-arm, safety study of the IMPEDE Embolization Plug in peripheral vascular embolization. The study was published this month in the peer-reviewed journal, Vascular, ahead […]

Preliminary Data from AAA-SHAPE to be Presented at VEITH 2022

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral vascular and neurovascular markets, announced preliminary six-month results from the AAA-SHAPE Safety Trial. Data will be presented during the 49th Annual VEITH Symposium in New York City on Tuesday, November 15, 2022. AAA-SHAPE is […]

Shape Memory Medical Names Anthony Lipp as Chief Commercial Officer

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of innovative products for cardiovascular and neurovascular therapies, is pleased to announce and welcome Anthony Lipp as Chief Commercial Officer. Anthony will be responsible for driving the development and implementation of global sales strategies of the company’s shape memory polymer embolization products […]

Shape Memory Medical Receives PMDA Approval for the IMPEDE-FX Embolization Plug

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc. announced today that it has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to market its IMPEDE®-FX Embolization Plug in Japan. Cosmotec, which is a Group Company of M3 Inc https://corporate.m3.com/en/ listed on the Tokyo Stock Exchange (TYO:2413), championed the approval process in […]

Shape Memory Medical Receives CE Mark for IMPEDE-FX RapidFill

Biodegradable Polymers Expand Options for Peripheral Embolization SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced CE Mark Approval for the IMPEDE-FX RapidFill™ Device, an expansion of the IMPEDE family of biodegradable peripheral vascular embolization plugs. Ted Ruppel, President and CEO of […]

Shape Memory Medical Names Mary Dennehy as Vice President of Marketing

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, is pleased to announce and welcome Mary Dennehy as Vice President of Marketing. Mary will be responsible for driving the development and implementation of global marketing strategies and initiatives that support commercialization of its […]

Shape Memory Medical Receives PMDA Approval for the IMPEDE® Embolization Plug Family

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc. announced today that its IMPEDE® Embolization Plugs have been approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA). Cosmotec, which is a Group Company of M3 Inc https://corporate.m3.com/en/ listed on the Tokyo Stock Exchange (TYO:2413), championed the approval process in Japan and is […]

Shape Memory Medical Receives CE Mark for the TrelliX® Embolic Coil System

SANTA CLARA, Calif.–(BUSINESS WIRE)–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. CE-marked indications include: Intracranial aneurysms, other neurovascular abnormalities […]

Shape Memory Medical Receives FDA Clearance for the IMPEDE® Embolization Plug

SANTA CLARA, Calif.–(BUSINESS WIRE)–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 […]