INVATIN developed the SYNAXIS, a first in class permanent aortic implantable apparatus for diversion of thromboembolic materials away from the brain. The device was developed to address the large population of patients with atrial fibrillation (AF), high stroke risk, and high bleeding risk. Patients that cannot be treated with other measures are the ultimate candidates for the SYNAXIS. Accordingly, it may be used in patients with intra-cardiac thrombi and in patients who are at risk for non-LAA related cerebral embolization. The device confers a new approach towards stroke prevention, and hold several advantages as compared with available technologies and drugs.
The INVATIN’s SYNAXIS is a novel one-piece cylindrical endovascular graft consisting of Nitinol frame and detachable filtering unit components. The stent graft is constructed of woven polyester fabric sewn to self-expanding nitinol stents with braided polyester and monofilament PTFE suture. The filter unit is designed and reinforced to sustain a high shearing forces and provide sustainability. The filter unit is positioned to cover all 3 arteries emerging from the aortic arch. Its design enables minimally invasive removal of the filtering apparatus with an intra-vascular biopsy forceps as a bailout procedure, with future application of replacing the filtering unit.
Animal studies have been completed, demonstrating both safety and preclinical efficacy in acute and chronic swine models of cerebral embolism.
Market size of stroke prevention in AF patients is estimated at 11.5B$/year. Several collaborations are being considered with manufacturers and distributors, as well as with traditional medical device companies. Among others, the company received investments from Clalit, the largest Israeli HMO, which may facilitate any local and international implementation.
Company’s Keywords:
device alternative for atrial fibrillation, stroke prevention, device alternative for anticoagulation drugs, device base stroke prevention, device alternative for noac, permanent stroke prevention
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