The initial cases with the transvenous tricuspid valve replacement (TTVR) system took place at Montefiore Hospital. This latest milestone comes just weeks after the China-based structural heart technology developer won CE mark for LuX-Valve Plus.
“This achievement marks a significant milestone in the global clinical progress of LuX-Valve Plus and reflects Jenscare’s commitment to advancing innovative therapies for patients with severe tricuspid regurgitation worldwide,” the company wrote on LinkedIn.
Jenscare designed LuX-Valve Plus, its proprietary, second-generation transvenous tricuspid valve replacement (TTVR) system, to treat patients with severe tricuspid regurgitation (TR).
The company says the valve works by functionally replacing the patient’s dysfunctional native tricuspid valve with a prosthetic valve stent. It does not require conventional open-heart surgery, using a transvascular delivery system approach.
Jenscare believes its approach simplifies the operation, with shorter procedure time, smaller incisions and less damage to heart tissue. Meanwhile, the valve itself offers multi-angle adjustability and steerability. It allows physicians to more conveniently adjust the release position and release angle of the valve. The company says this increases the product’s safety profile.
Currently, the TTVR market features the Edwards Evoque system, while Venus Medtech advances its Cardiovalve TTVR device. Vdyne and TriCares also have TTVR options under development, among other potential entrants.
Dr. Azeem Latib, Montefiore Hospital, said:
“Performing the first case in the TRINITY U.S. pivotal trial is an exciting milestone for our team at Montefiore. The LuX-Valve Plus expands treatment options for patients who previously had limited alternatives due to large annular dimensions or poor imaging conditions. Dr. Edwin Ho and I believe the procedure is straightforward to learn and can be performed consistently across a broad range of patients. We look forward to enrolling additional patients and bringing this innovative therapy to those who need it.”
