• Safer Transcatheter Aortic Valve Implantation (TAVI)

    HVT Medical is developing a novel device to enable safer and more effective aortic valve replacement procedures.

  • The Need

    Transcatheter aortic valve implantation (TAVI) has become an established treatment for severe aortic stenosis and is being performed for growing numbers of patients. Patients with unusually large aortic valve cusps (an aortic cusp is one of the triangular parts of the valve that opens and closes with the flow of blood) or with small aortic roots are at risk with this procedure because the implanted valve may push the cusps upward, blocking one of the coronary arteries. Currently approximately 20% of all patients previously treated with TAVI are contraindicated to undergo it again, and the proposed technology is intended to enable more of this population to benefit from the life-saving procedure. This condition is relevant both for native calcified valves and especially for prosthetic valves which tend to lose functionality gradually within 5-10 years.

  • HVT Medical’s Solution

    HVT Medical’s Splitter device performs cusp splitting during TAVI procedures to help reduce risk of coronary occlusion.

    • The device enables precision in splitting the cusp by applying an advanced catheter, guidewire and cutting mechanism to create an intentional laceration or excision of valve's cusp tissue.
    • Once the excised valve tissue is removed from the aorta, the TAVI procedure can be performed using the same guidewire.
  • Market Potential

    The implantation of aortic heart valves by TAVI is becoming an increasingly common procedure. In 2019 some 72,000 such procedures were performed worldwide and they have become more common than open-surgery implantations, coinciding with the U.S. Food and Drug Administration (FDA) approval of TAVR for low-risk patients.

    • Using HVT’s Splitter before prosthetic valve implantation may help reduce the risk of occlusion to the orifice of the coronaries, saving consequent healthcare costs and of course, saving lives.
    • By enabling more TAVI procedures, the Splitter will help increase revenues for healthcare providers, while leading industry players (Edwards, Medtronic and others) will benefit from increased sales of replacement prosthetic valves.

Proof of concept trial in pigs (planned for 2022) is the primary milestone to demonstrate the safety and effectiveness of HVT Medical’s splitter technology.

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