Medical therapies developer Shape Memory Medical has obtained US Food and Drug Administration (FDA) 510(k) clearance for its Impede Embolization Plug.
The approval covers use of the plug to obstruct or decrease the blood flow rate in the peripheral vasculature up to 10mm in diameter.
Available in three sizes, the new device features the Shape Memory Polymer (SMP) technology, similar to its sister products in the Impede embolisation devices range.
The SMP technology, which was developed at Texas A&M University and Lawrence Livermore National Laboratory, is based on porous polymeric materials.
Upon delivery into a blood vessel, the polymeric materials can transform from a catheter-deliverable shape into a ‘memorised’ conformable shape, which is comparatively larger.
Shape Memory Medical president and CEO Ted Ruppel said: “The Impede Embolization Plug is an exciting development in embolisation technology, expanding the options open to physicians treating conditions requiring occlusion of the peripheral vasculature.”
In August last year, the embolisation plug secured the CE-Mark and has been used for the treatment of patients in New Zealand and various European Union (EU) countries.
Shape Memory Medical primarily develops medical therapies using its proprietary polymers for embolisation. It focuses on commercialising stable and predictable embolisation solutions for different clinical applications.
The company intends to expand the use of SMP technology for a variety of clinical uses, including neurovascular applications.
Currently, Shape Memory has a total of 26 US patents issued for internally developed as well as licensed technologies.