VEITH 2Concept Medical Inc22 witnessed a surge of supporting clinical data for Sirolimus Coated Balloon in the treatment of Below-the-Knee (BTK) disease. Concept Medical Inc. hosted a lunch symposium titled 'Sirolimus Coated Balloon in PAD Treatment: Choice of The Future' which explored the utility of Sirolimus Coated Balloon treatment in PAD. The session was chaired by Prof. Sahil Parikh, co-moderated by Prof. Edward Choke and Prof. Aloke Finn with interesting presentations by Prof. Ulf Teichgraeber and Prof. Francesco Liistro.
One of the highlights of the session was the follow up data of clinical outcomes of the XTOSI Trial. XTOSI (Xtreme Touch Sirolimus coated PTA balloon) is a single arm trial for Sirolimus Coated Balloon (MagicTouch PTA) investigating the clinical use and safety of the device in the treatment of infrainguinal Peripheral Arterial Disease (PAD). This prospective, premarket, non-randomized, all comers single-arm study, led by PI Prof. Edward Choke enrolled 50 patients to study the Magic Touch PTA Sirolimus Coated Balloon (Concept Medical Inc.) at Sengkang General Hospital, Singapore. It is the world's first trial of Sirolimus Coated Balloon for BTK disease and has the longest follow up data. While the primary endpoints already suggested promising patency and safety at 6 months, the data presented at VEITH 2022 shed more light on the longer-term efficacy and the safety of the Sirolimus Coated Balloon.
Prof. Edward Choke, further presented updates on the FUTURE SFA and FUTURE BTK RCTs, a family of randomised trials set to enrol 279 and 219 patients respectively, against standard uncoated balloon in 2:1 fashion and are ongoing in Singapore, Taiwan and Thailand. FUTURE BTK has already completed 25% of its enrolment target, credits to the principal investigators of all sites involved.
Sirolimus Coated Balloon for PAD continues its march, knocking on the doors of the US and lighting up the iconic New York Times Square with a dazzling display of the study results of XTOSI and the recruitment status of the FUTURE BTK.
Watch the complete session to know more about exciting clinical data: https://youtu.be/2xokmMuhzuc
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Photo: https://mma.prnewswire.com/media/1960489/Edward_Choke_MagicTouch_XTOSI.jpg
The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the Company's Sirolimus coated balloon. The Company has already received three other pivotal IDE approvals for its SCB MagicTouch family of products for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee