Shape Memory Medical 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 embolisation plug family and the TrelliX embolic coil. The patient was treated by Thomas Maldonado (NYU Grossman School of Medicine and NYU Langone Health, New York, USA).
“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-EVAR [endovascular aneurysm repair] type II endoleak,” said Maldonado.
According to a company press release, shape memory polymer is a new concept in medical devices, built on 25 years of polymer research and expertise initiated at Lawrence Livermore National Laboratory (LLNL; Livermore, California) and further developed at Texas A&M University (College Station, USA). Shape memory polymer features a porous, compliant polyurethane embolic material that enables conversion to organised thrombus followed by gradual healthy tissue formation. In 2009, Shape Memory Medical was formed to develop and commercialise devices for use in the peripheral and neurovascular embolisation markets. An emerging alternative to traditional, bare metal embolisation devices, shape memory polymer is soft and conformable, and the material is radiolucent which improves visibility of the surrounding anatomy during and after the procedure.
“This milestone is especially significant for Shape Memory Medical,” said Ted Ruppel, chief executive officer. “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 is also 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.
Since the launch of the Impede embolisation plug family in the USA, Europe, and Japan and the TrelliX embolic coil in Europe, these novel devices have been used by vascular surgeons and interventional radiologists in over 25 countries. The growing body of evidence presented from the podium and in the literature has raised physician awareness and interest in the Impede and TrelliX devices, including data from the TrelliX APEX study and the IMPEDE EMBO postmarket surveillance study. The Impede-FX RapidFill device is also currently 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 endovascular aneurysm repair (EVAR). “Early AAA-SHAPE results are encouraging,” said Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands), principal investigator, AAA-SHAPE Netherlands. “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 healthcare systems.” The AAA-SHAPE trial is ongoing, with one-year results expected to be announced in 2023.