Concept Medical Reports Index Patient Enrollment in World’s 1st RCT with Sirolimus Coated Balloon

For the RX of Superficial Femoral Artery in Peripheral Artery Disease

September 14, 2020

Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the FUTURE SFA (Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Superficial Femoral Artery and Popliteal Artery Disease).

Concept Medical notes the index patient was successfully enrolled on 11th September in Singapore.

FUTURE SFA is a randomized, double-blind, placebo-controlled, multi-center trial to determine the effectiveness of MagicTouch PTA sirolimus drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal arterial disease.

The burden of peripheral arterial disease (PAD) is high globally. Its burden is likely to grow in the coming years given the rising trends in key risk factors such as age and diabetes. In its most advanced stage, patients present as critical limb ischemia (CLI) and many end up with leg amputations.

Current standard of care for severe PAD is revascularization, the majority of which involves the use of balloon angioplasty to unblock the vessel and restore blood flow to the leg. However, these vessels frequently become blocked again, resulting in repeated procedures which is potentially dangerous and may result in loss of limb or even life.

Local drug delivery using drug coated balloons (DCBs) during angioplasty can successfully deliver anti-proliferative drugs to the lesions in the artery, with the aim of keeping the vessel open for longer. Sirolimus coated balloons are considered to be the next new generation of DCBs and the novel MagicTouch PTA sirolimus coated balloon (SCB), has emerged as one of the most promising transcatheter technologies in preventing restenosis for diseased arteries.

The principal investigator of FUTURE-SFA is Associate Professor Edward Choke from the Department of General Surgery (Vascular Surgery) at the Sengkang General Hospital, Singapore reports Concept Medical.

Associate Professor Edward Choke said, “I am inspired by the bold, imaginative and futuristic concepts presented by the Nanolute technology of the MagicTouch PTA sirolimus coated balloon. In contrast to other contemporary technologies, MagicTouch PTA offers a solution that optimizes both the deliverability and the absorption of sirolimus into the vessel wall.”

He added, “Initial experience with the XTOSI first in man study suggested that MagicTouch PTA can provide an effective way of revascularization for PAD patients, by keeping the vessels open longer and reducing the need of repeated angioplasty procedures. I look forward to the FUTURE-SFA randomized controlled trial, which will test whether the Magic Touch PTA sirolimus coated balloon can improve the patencies of femoral and popliteal arteries in PAD patients. We hope to establish whether SCB will emerge as the new standard of care which will impact the way we treat PAD.”

The trial will enrol 153 patients with Rutherford class 3 to 6 PAD. These subjects will be randomized in 2:1 fashion to receive either Magic Touch PTA or standard balloon angioplasty.

Primary outcome will be primary patency at 6 months, defined as duplex peak systolic velocity ratio (PSVR) of 2.4 or less.

The trial is designed to follow a rigorous blinding protocol in order to minimize bias. Patients, care providers, investigators, and outcome assessors, including vascular technologists performing the duplex ultrasound, will be blinded to the treatment allocations. The patients will be followed up for two years.

[NCT04511234 – Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease (FUTURE-SFA)]

Rt

Hot this week

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."

Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.