SANTA CLARA, Calif.–(BUSINESS WIRE)–#lnll–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.
The IMPEDE family of peripheral vascular embolization products all include shape memory polymer (SMP), the core technology of Shape Memory Medical’s expanding product lines. SMP is designed to transition between two shapes, based on its environment. Therefore, it can be crimped for delivery through a catheter, and it self-expands when exposed to blood and body temperature. The feature that really sets SMP apart from other embolization technologies is that it is a porous embolic scaffold. It does not just mechanically ‘block the vessel’ like some vascular plugs – the porous embolic scaffold also supports the initial clotting process as small interconnected clots rapidly form throughout its structure. The porous scaffold is a biocompatible tissue scaffold that promotes rapid conversion to organized thrombus, followed by cell-mediated material degradation and collagen deposition without chronic-active inflammation, as demonstrated in pre-clinical studies.
A recent publication (https://doi.org/10.1021/acsbiomaterials.9b00895) 1 in the ACS Biomaterials Science & Engineering journal describes the cellular-level mechanisms in play as SMP initially embolizes a vessel and then forms a stable occlusion through 90 days post-implantation in a porcine model. The authors observed that implantation initiates an acute inflammatory response, in combination with the clotting cascade, to form an initial thrombus throughout the porous embolic scaffold. The unique nature of SMP demonstrated progressive healing over 90 days with gradual, noninflammatory replacement of SMP foam struts with cellular, collagenous connective tissue. Importantly, this series of cellular processes results in a stable vessel occlusion at 90 days post-implantation, with no microscopic indication of a sustained chronic-active inflammatory response. The publication’s authors noted that the quality of the occlusion was superior when compared to control embolic devices in their study.
Shape Memory Medical’s President and CEO, Ted Ruppel, said, “The R&D 100 Award is well-deserved recognition of the ongoing basic science supporting the core technology of our clinical products. Our partnerships with Texas A&M University and Lawrence Livermore National Lab have proven to be exciting and productive.”
SMP technology was initially researched and developed at Lawrence Livermore National Laboratory and Texas A&M University. Shape Memory Medical was founded to develop and commercialize solutions for a variety of clinical applications using this novel technology. The company continues to develop innovative materials and therapies for peripheral vascular and neurovascular applications. Shape Memory Medical has licenses to 30 issued patents for its SMP technology, as well as 40 patent applications in process alongside multiple FDA cleared and CE marked products currently available for use.
About Shape Memory Medical
Shape Memory Medical Inc., based in Santa Clara, California, is committed to developing multiple medical therapies with their novel shape memory polymers. Products include IMPEDE® and IMPEDE® FX devices for peripheral embolization applications, and the TrelliX® Embolic Coil for neurovascular applications. The company’s TrelliX® Embolic Coils have not been cleared or approved by FDA, and are not commercially available in the United States. For more information, visit www.shapemem.com.
1 Three of the authors (Todd Landsman, Fred Clubb and Duncan Maitland) are employed by, have consulting relationships with and/or hold equity in Shape Memory Medical.
Shape Memory Medical Inc.
Ted Ruppel, 408-649-5175