Recently, Shape Memory Medical has been approved by the US Food and Drug Administration to sell its obstruction plugs in the US market. The device is based on shape memory polymer (SMP) technology and is designed to reduce or impede blood flow in the vasculature. .
In 2017, the technology funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), approved in Europe and other countries that recognize the CE mark, is a new embolization method that involves inducing or producing blood clots.
During the embolization process, the catheter is passed through the vascular system to direct the material that condenses the blood vessels into the treatment site. NIBIB says on its website: 'Currently, the most common material used for this procedure is a coil of platinum or titanium wire. These coils fill the area and cause clots, which stabilize the blood vessels. However, the coil can cause subsequent problems, including inflammation, vascular perforation and incomplete healing. These complications can lead to additional treatment for patients to repair the blood vessels again.
In contrast, SMP technology uses low-density polyurethane during the embolization process. Shape Memory Medical explains that the foam formulation and pore size can be modified into a range of properties. After the SMP foam is first prototyped, it is crimped. A secondary shape that can be transported by a catheter that, upon delivery to a blood vessel, restores its original unfolded shape.
According to NIBIB, obstructing the embolization device allows the blood vessels to be more evenly filled and produces a more uniform blood clot, which has been shown in preclinical tests, and the test results are more supportive of the treatment of the single device, rather than Treatment of several metal coils.
The obstructive SMP technology was developed from Texas A&M University and Lawrence Livermore National Laboratory. Shape Memory Medical continues to research SMP technology to expand its clinical applications, including nerve and blood vessel applications. And licensed technology, Shape Memory Medical now has 26 US patents and several patents under global review.