HighLife SAS, a medtech company focused on the development of a unique Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today that its technology was successfully used for the first time in China.
The procedure took place at West China Hospital of Sichuan University in Chengdu, PRC, and was performed by Prof Mao Chen, interventional cardiologist and his team. The case was carried out in close collaboration with Dr Nicolo Piazza, interventional cardiologist at McGill University in Montreal who supported the procedure over a remote video connection (i.e. teleproctoring). The patient was a 74-year-old female with acute heart failure, MR 3+, persistent AF, hypertension and diabetes.
“The patient’s condition required an intervention to treat her MR and a beating heart procedure was the best option given her comorbidities. She remained stable throughout the procedure and the MR was completely eliminated after implantation of the valve.” said Prof Chen at the end of the procedure.
“I am very happy I could support Prof Chen and his team during the procedure and share some of my own experience over the distance since the current travel limitations did not allow for a face-to-face training.” said Dr Piazza.
This percutaneous transcatheter intervention is believed to be the first use in China and even the first use in Asia of any trans-septal mitral valve replacement technology on a beating heart in a patient.
HighLife and Peijia Medical entered into a technology transfer agreement in December 2020. Technical, manufacturing transfer, and clinical training milestones were rapidly achieved using a completely remote process. In only 12 months, the successful partnership between HighLife and Peijia Medical has resulted in the first clinical use of the HighLife TSMVR technology in China.
The patient was treated as part of a single center clinical trial run by Prof Mao Chen at his institution West China Hospital of Sichuan University in Chengdu, PRC, which is sponsored by Peijia Medical.
Dr Nicolo Piazza is a medical advisor to Peijia Medical for its clinical program. He also is the main worldwide proctor of HighLife’s clinical trials and to-date has the most hands-on and remote-proctoring experience globally with HighLife’s TSMVR technology.
HighLife SAS was established in 2010 and is headquartered in Paris, France, with a facility in Irvine, CA (USA). It is focused on the development of a novel trans-septal mitral replacement system for treating mitral regurgitation. The technology aims at a beating heart procedure, reducing trauma to the patients through a purely endovascular approach.
Caution: The HighLife Trans-Septal Mitral Valve (TSMV) is an investigational device and not available for sale.
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