Shape Memory Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Impede embolization plug.
The Impede embolization plug has been developed to block or reduce the rate of blood flow in the peripheral vasculature.
The company is providing the embolization plug in three sizes for the treatment of vessels up to 10mm in diameter.
In August 2017, the firm secured CE mark approval for Impede embolization plug. It is also approved to patients in New Zealand and several EU countries.
Shape Memory Medical president and CEO Ted Ruppel said: “The IMPEDE Embolization Plug is an exciting development in embolization technology, expanding the options open to physicians treating conditions requiring occlusion of the peripheral vasculature.”
The University of Minnesota Health radiologist Dr. Jafar Golzarian said: “It is exciting to see the approval of new developments in embolization technology, offering physicians a new alternative to embolization coils.”
Featuring Shape Memory Polymer (SMP) technology, the Impede embolization plug was developed at Texas A&M University and Lawrence Livermore National Laboratory.
Shape Memory Medical said that it will commercialize stable and predictable embolization solutions for a variety of clinical applications.
The SMP technology is comprised of porous polymeric materials that can change from a catheter-deliverable shape to a memorized larger conformable shape when delivered into a blood vessel.
The company is engaged in the development of SMP technology for an expanded range of clinical uses, including neurovascular applications.
With both internally developed and licensed technologies, the firm has 26 issued US patents and multiple patents under review on a global basis. The rational property includes the use of SMP for different clinical applications.
The National Institutes of Health has provided a portion of funding for the development of company’s solutions.
Based in Santa Clara of California, Shape Memory Medical is involved in the development of multiple medical therapies with their novel polymer solutions for embolization.