Shape Memory Medical announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Impede embolization plug. The device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in three sizes, to treat vessels up to 10mm in diameter.
The Impede embolization plug received CE marking in August 2017 and has been used to treat patients in New Zealand and in several countries in the European Union.
Speaking about the device, Jafar Golzarian, interventional radiologist with University of Minnesota Health, Minnesota, USA, stated, “It is exciting to see the approval of new developments in embolization technology, offering physicians a new alternative to embolization coils.”
Commenting on this regulatory milestone and ongoing clinical usage, Shape Memory Medical’s 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 devices feature proprietary Shape Memory Polymer (SMP) technology developed at Texas A&M University and Lawrence Livermore National Laboratory. Shape Memory Medical was founded to commercialise stable, predictable embolization solutions for a variety of clinical applications. The SMP technology includes porous polymeric materials capable of changing from a catheter-deliverable shape to a “memorised” larger conformable shape when delivered into a blood vessel. The company continues to develop SMP technology for an expanded range of clinical uses, including neurovascular applications.
With both internally developed and licensed technologies, Shape Memory has 26 issued US patents and multiple patents under review on a worldwide basis. This intellectual property includes the use of SMP for a variety of clinical applications, a press release from the company states.