Shape Memory Medical Provides Update on Embolotherapy Device Portfolio

August 3, 2022—Shape Memory Medical Inc. announced a milestone for the Impede embolization plug family and the Trellix embolic coil, which are part of the company’s portfolio of shape memory polymer embolotherapy devices. The company advised that the 1,500th patient was treated with the devices by Thomas Maldonado, MD, Professor of Surgery, NYU Grossman School of Medicine, and Director of the Aortic Center at NYU Langone Health in New York, New York.

Dr. Maldonado commented in the company’s press release, “We were excited to perform our first case using shape memory polymer technology, and in this particular case for the occlusion of the internal iliac artery for prevention of post–endovascular aneurysm repair (EVAR) type II endoleak.”

The company’s shape memory polymer features a porous, compliant polyurethane embolic material that enables conversion to organized thrombus followed by gradual healthy tissue formation. The shape memory polymer is soft and conformable, and the material is radiolucent, which improves visibility of the surrounding anatomy during and after the procedure. The technology was developed as an alternative to traditional, bare metal embolization devices.

Ted Ruppel, Chief Executive Officer of Shape Memory Medical, commented in the company’s press release, “This milestone is especially significant for Shape Memory Medical. This accomplishment is only the beginning of our plans for this emerging technology, with a product pipeline focused on the development of shape memory polymer solutions for aortic aneurysms and aortic dissection.”

The company advised it is pursuing research and development and corporate licensing partnerships for potential applications across multiple therapeutic areas such as aortic therapies, structural heart, biopsy, and drug delivery.

The Impede embolization plug family was launched in the United States, Europe, and Japan. The Trellix embolic coil is available in Europe.

The devices have been studied in the Trellix APEX study and the Impede EMBO postmarket surveillance study. Additionally, the Impede-FX RapidFill device is also being evaluated in a first-in-human safety and efficacy trial for a potential new indication for abdominal aortic aneurysm (AAA) sac management during elective EVAR.

The AAA-SHAPE trial is ongoing with 1-year results expected to be announced in 2023.

“Early AAA-SHAPE results are encouraging,” commented Professor Michel Reijnen, MD, a vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands. Prof. Reijnen is Principal Investigator of the AAA-SHAPE Netherlands trial, continued, “Shape memory polymer technology has the potential to improve post-EVAR sac regression, reduce secondary interventions, and reduce the burden for our patients as well as for health care systems.”

In Europe, the Trellix embolic coil neurovascular embolization device received CE Mark approval. The company’s peripheral embolization products, the Impede and Impede-FX embolization plugs and Impede-FX RapidFill device have CE Mark approval. They 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. The Impede and Impede-FX embolization plugs are approved in Japan.

The Trellix embolic coil and Impede-FX RapidFill device are not available in the United States or Japan, advised the company.