US-based medical device company Laplace Interventional has successfully completed the first-in-human procedure in an early feasibility study (EFS) with its TTVR system.
The EFS clinical protocol is approved by the US Food and Drug Administration (FDA) and the procedure aims to evaluate the safety and technical feasibility of the Laplace TTVR system.
This procedure was performed at Tucson Medical Center by Dr Thomas Waggoner and Dr George Makdisi from the US Heart and Vascular Institute, along with Dr Pradeep Yadav from Piedmont Heart Institute in attendance as a clinical proctor.
The patient who underwent the transcatheter tricuspid valve replacement was discharged and is currently recovering.
Waggoner said: “We are proud to be the first medical centre in the world to successfully implant a patient with Laplace Interventional’s cutting-edge new technology to treat tricuspid regurgitation. Thanks to the FDA’s dedication to the EFS programme, we are able to offer our patients new options for TTVR as early as possible through studies such as this.”
The TTVR system is intended to reduce or eliminate the effects of tricuspid regurgitation (TR) in adults who have severe or more symptomatic TR despite medical therapy.
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It is specifically designed to offer a less invasive alternative to open-heart surgery by delivering the replacement valve through the patient’s vasculature.
Laplace Interventional founder and CEO Ramji Iyer said: “The successful completion of the FIH procedure in the US EFS study marks a significant milestone for Laplace’s technology and in understanding its potential to benefit a significant number of patients with tricuspid regurgitation.”
Last year, Laplace Interventional successfully closed a $12.9m Series B financing round to advance its strategy for its first-in-human trial of its transcatheter valve system.
The financing was co-led by ShangBay Capital and Features Capital, with additional participation from Engage Venture Partners, and JWC Ventures.
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- Source: https://www.medicaldevice-network.com/news/laplace-human-ttvr/
