First patient enrolled in Lutonix drug-coated balloon pivotal trial

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Lutonix announced the enrolment of the first patient in the LEVANT 2 clinical trial, a global, multicentre, randomised trial which evaluates the safety and efficacy of the Moxy drug-coated balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease. The first case was performed by Jeff Goldstein at St. John’s Hospital, Springfield, USA.

LEVANT 2 is the first drug-coated balloon IDE trial to be approved by the FDA, and is being conducted to support a pre-market application for US approval of the company’s Moxy balloon. The trial is expected to randomise approximately 476 patients at up to 55 hospitals worldwide. LEVANT 2 is the largest randomised peripheral drug-coated balloon trial to date, and one of the largest peripheral vascular studies ever conducted.

Randomised patients in LEVANT 2 will be followed for a total of five years and independent core laboratories will verify trial outcomes. The primary safety endpoint is a composite of freedom from all-cause peri-operative death and freedom at one year from amputation, re-intervention and death. The primary efficacy endpoint is primary patency at one year. Co-principal investigators of the trial are Kenneth Rosenfield, Massachusetts General Hospital, Boston, USA and Dierk Scheinert, Heart Center Leipzig/Park Hospital, Leipzig, Germany.

“We are very pleased to be the first centre to contribute to such an important trial. We believe drug-coated balloons may play an important role in the future of peripheral interventions, and we are proud to be involved in such a well-designed, carefully controlled trial to explore this promising new therapy,” said Goldstein, site principal investigator at St. John’s Hospital.

“With eight to twelve million patients known to suffer from peripheral arterial disease and a paucity of durable, highly effective therapies, patients and physicians are in need of a game-changing treatment modality. The LEVANT 2 trial will help us determine whether a drug-coated balloon can fill this gap,” co-investigator Krishna Rocha-Singh added.

Drug-coated balloons have received growing attention in recent years as physicians increasingly look for effective ways to treat diseased leg arteries without having to leave a permanent stent implant behind. Like the drug-eluting stents commonly used in the heart, the Moxy balloon delivers a powerful restenosis-fighting drug to the artery. However, unlike a stent, the Moxy balloon is removed from the body after use, leaving nothing but the drug behind in the artery.

Physician enthusiasm for the drug-coated balloon concept has been bolstered by encouraging results from early trials like LEVANT 1, a precedent study to LEVANT 2. LEVANT 1 was a 101-patient randomised trial in which the Moxy balloon was compared to standard angioplasty for the treatment of diseased femoropopliteal arteries. The trial showed the Moxy balloon had the ability to safely and substantially inhibit restenosis.

“There is tremendous enthusiasm within the medical community about the potential for drug-coated balloons to improve outcomes for our patients,” explained Rosenfield. “However, because the field is young, we need data from large, randomised controlled clinical trials that are independently validated. Because of its scientific rigor, LEVANT 2 will help address this need. On behalf of Dr. Scheinert and myself, we congratulate St. John’s on their enrolment of the first patient in this landmark trial.”

About the Moxy drug-coated balloon

The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with an anti-restenotic drug designed to help keep arteries open and free from re-blockage. During the procedure, the Moxy balloon is inflated for 30 seconds during which it opens up the artery to restore blood flow, and delivers the drug to the artery wall. The Moxy balloon is then removed from the body leaving nothing behind but the drug coating, which works inside the artery over time to prevent restenosis. The Moxy balloon is an investigational device, which is not approved for sale in the United States.