Singapore-based medical device company Genesis MedTech has received the Food and Drug Administration (FDA) approval for its Chocolate Touch Drug-coated Balloon (DCB).
Chocolate Touch is indicated for percutaneous transluminal angioplasty (PTA) for the treatment of peripheral artery disease (PAD) in native femoral or popliteal arteries.
The PTA catheter is developed by the US-based medical device company TriReme Medical, which was acquired by Genesis in August 2020.
Chocolate Touch is designed to open in small sections using pillow-like structures coated with a therapeutic agent, to provide an alternative treatment to traditional DCB angioplasty.
It is the world’s first and only balloon catheter that integrates therapeutic agent delivery with an advanced angioplasty platform, for the treatment of PAD, said the medical device firm.
Genesis MedTech Group chairman and CEO Warren Wang said: “The Chocolate Touch FDA approval provides U.S. physicians and their patients a next-generation drug-coated balloon with exceptional safety and efficacy to use in treating patients with PAD.
“This approval demonstrates our commitment to bring innovation solutions to enhance the standard of care of millions of patients suffering from peripheral vascular diseases.”
In the clinical studies, Chocolate Touch DCB has shown superior patency and non-inferior safety compared with Lutonix DCB in patients with the symptomatic femoropopliteal disease.
The DCB showed a statistically superior 12-month True DCB Success, a measure of the target vessel without the need for bail-out stenting, which is the study’s primary efficacy endpoint.
The primary patency was 83.3% for the Chocolate Touch and 73% for Lutonix DCB, by Kaplan-Meier (KM) estimate.
Chocolate Touch showed 88.9% freedom from major adverse events (MAE) at 12 months, which is a primary safety endpoint, compared to 84.6% for Lutonix DCB.
Also, the DCB resulted in the lowest all-cause KM mortality rate value of 6.7% for 3 years, compared to reported mortality for FDA-approved DCBs in clinical studies.
Chocolate Touch study co-principal investigator Mehdi H Shishehbor said: “I am very excited to see the Chocolate Touch, a next-generation drug-coated balloon, is now available for patients across the United States.
“This technology is an important tool in the armamentarium for the treatment of patients with peripheral artery disease.”
In a separate development, the company has opened its advanced medtech campus featuring an innovation centre, and two R&D and production centres in a site spanning 135,333m2 in Wuxi, China.
The innovation centre is designed to provide an open educational platform to enable deeper engagement and interaction between Genesis MedTech and medical professionals.
It provides medical professionals with access to clinical training on the latest innovations in the fields such as minimally invasive surgery, vascular, and structural heart disease.
The Campus also includes an R&D and Manufacturing Centre, which supports the development and manufacturing of high-quality medical devices.
Genesis MedTech chairman and CEO Warren Wang said: “We are trying to play an integral role in MedTech innovation that will revolutionise how medtech development is intimately integrated with the practical needs of medical professionals.
“Through training and exchanges, we can better understand clinical needs, stimulate technological innovation and expand product development.
“The campus will be an ultramodern nexus for R&D, manufacturing, training and exchange, providing our R&D teams and global experts with an open platform to explore innovations from ground zero, becoming an exploration and production centre for new technologies and products.”
