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 Inc. said, "We are excited to introduce IMPEDE-FX RapidFill to the endovascular community in Europe. This is the first device on the market that enables the delivery of multiple embolization plugs in a single application, which may provide an advantage in cases where the goal is to quickly fill and occlude large spaces such as aneurysms, venous insufficiency, or trauma with reduced procedure and fluoroscopy time, contrast media, and blood loss."

The IMPEDE family includes the IMPEDE^® Embolization Plug, the IMPEDE-FX Embolization Plug, and now IMPEDE-FX RapidFill which consists of five IMPEDE-FX-12 embolization plugs preloaded into a single delivery introducer. This peripheral vascular platform incorporates the Company’s novel Shape Memory Polymer technology, a porous, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus. Pre-clinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling compared to traditional coils and plugs, stable clot formation for reduced intra-device recanalization, and progressive, intradevice healing as the material biodegrades.

To date, nearly 600 patients have been treated worldwide with the IMPEDE family of devices.

About Shape Memory Medical

Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary Shape Memory Polymers. Neurovascular embolization products include the TrelliX^® Embolic Coil; CE marked for use in the EU. Peripheral embolization products include the IMPEDE^® and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. IMPEDE-FX RapidFill is not cleared for use, and is not available for sale, in the United States. For more information, visit www.shapemem.com.