Concept Medical's Sirolimus-Coated Balloon MagicTouch AVF Receives FDA Breakthrough Device Designation for Hemodialysis Access Complications

On September 2, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that medical device company Concept Medical announced its sirolimus-coated drug-coated balloon (DCB) catheter, MagicTouch AVF (MagicTouch), had received FDA Breakthrough Device Designation.

Following the Breakthrough Device Designation for Magic Touch, the FDA will grant CMI priority review and engage in communications regarding device development, clinical trial protocols, and commercialization decisions.

Concept Medical, headquartered in Florida, USA, is a medical device developer. The company’s MagicTouch is a sirolimus-coated balloon indicated for percutaneous transluminal angioplasty (PTA), which addresses complications arising from hemodialysis access procedures.

Hemodialysis is a treatment for renal failure that uses a machine to circulate the patient’s blood through an external filter (i.e., a dialysis machine). This procedure requires surgical creation of vascular access in the forearm.

Patients requiring long-term dialysis utilize two types of vascular access: arteriovenous fistula (AVF) and arteriovenous graft (AVG). Common complications associated with AVFs and AVGs include infection, stenosis, thrombosis, aneurysm, and limb ischemia. Percutaneous transluminal angioplasty (PTA) can be used to manage these complications.

PTA can unblock occluded vessels using a small catheter with a “balloon” at one end. Existing techniques employ drug-delivery devices to administer agents that inhibit inflammatory and proliferative pathways. Sirolimus is the drug of choice widely used in PTA.

In 2018, the first study on the efficacy and safety of Magic Touch in percutaneous transluminal angioplasty (PTA) was initiated in Singapore. Conducted at Singapore General Hospital, the study was led by Dr. Tan Chieh Suai, with a team comprising interventional nephrologists, vascular surgeons, and interventional radiologists.

Dr. Tjun Yip Tang, Associate Professor at Singapore General Hospital, stated, “Magic Touch is promising, with a high level of safety and patient acceptance.”

Dr. Tan Chieh Suai stated, “The Breakthrough Device Designation for Magic Touch is welcome news for dialysis patients, as there is an urgent need in the dialysis community for effective and durable treatment options. We are greatly encouraged by the early clinical results from the Singapore study, and we thank all the patients who participated. I was particularly moved by feedback from one patient: ‘So far, so good. This new study has helped me significantly by sparing me from repeated surgeries; previously, I required an interventional procedure every three months. It allows me to spend more time at home rather than in the hospital.’ We look forward to initiating a larger-scale, multicenter, randomized study to validate our findings.”

(Compiled by Hu Yifan)