Laguna Tech USA has conducted more successful clinical cases in aortic regurgitation patients with its Zeta balloon-expandable aortic valve system and the Alpha self-expanding aortic valve system.
As per a 25 October statement, the US-based company announced it has completed a first-in-human clinical case with its Zeta system. Laguna also added that additional patients have been successfully treated with its Alpha self-expanding aortic valve system in a feasibility study.
In addition, Laguna commented that the device has so far led to complete resolution of aortic regurgitation in two patients, with results maintained at a 30-day follow-up.
Aortic regurgitation occurs when blood flows back through the aortic valve due to the aortic valve not closing fully.
The Alpha and Zeta systems are both transcatheter valves with six arms for positioning into the aortic annulus – a fibrous ring located at the aortic valve – and cusps. Whilst Alpha is a self-expanding valve, Zeta is balloon-expandable.
The feasibility study for the Alpha system is being conducted at the Tbilisi Heart and Vascular Clinic in Georgia and Instituto Nacional de Torax in Santiago, Chile.
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A market model by GlobalData estimated the global transcatheter aortic valve replacement market was worth $6.2bn in 2021. This is expected to triple by 2033, reaching $18.8bn.
This week, JenaValve Technology also announced data from a trial investigating its Trilogy system for aortic regurgitation. Its device met primary and safety endpoints.
Transcatheter aortic valve replacement was originally indicated for the treatment of aortic stenosis. Although it is not yet used on a regular basis for aortic regurgitation, it is an option for patients with the condition who are not eligible for surgical aortic valve replacement.
The study’s lead primary investigator and University of Virginia cardiologist Dr Scott Lim said: “[The devices] allowed us to successfully and percutaneously treat these first patients at high surgical risk with severe aortic regurgitation, and in one case, with concomitant significant calcific aortic stenosis.
“I look forward to these novel transcatheter aortic valves being further investigated in larger studies, as this initial experience is quite encouraging toward helping us address a significant unmet patient need in those with complex aortic valve disease.”