Lutonix receives CE mark and FDA approval to initiate pivotal IDE drug-coated balloon trial


On 28 June 2011, Lutonix announced receiving approval from the FDA to begin enrolment in its LEVANT 2 IDE clinical trial for the treatment of peripheral arterial disease, along with receipt of CE mark for its drug-coated balloon and ISO certification. Lutonix is the first company to receive approval from the FDA to initiate a drug-coated balloon trial. 

The company also announced two new additions to its leadership team. Shawn McCormick was named chief operating officer and will oversee manufacturing, R&D, finance and administration for the company. Leslie Trigg was named executive vice president, Marketing and Commercial Strategy and will oversee all commercialisation aspects of the business.


LEVANT 2 is a global, multicentre, randomised study evaluating the safety and efficacy of the Moxy drug-coated balloon compared to a standard angioplasty balloon for treating diseased leg arteries above the knee. The trial is designed to support an application to the US FDA for approval of the Moxy balloon. Co-principal investigators for this international study are Ken Rosenfield, Massachusetts General Hospital, Boston, USA, and Dierk Scheinert, University of Leipzig, Leipzig, Germany.


The LEVANT 2 trial was preceded by LEVANT 1, a multicentre, prospective randomised trial of 101 patients with peripheral arterial disease. In this study, the Moxy balloon was compared to standard angioplasty. Data presented during the 2010 Transcatheter Cardiovascular Therapeutics meeting showed that the Moxy balloon had the ability to safely and substantially inhibit restenosis.


“Finding a durable treatment for peripheral arterial disease has proven to be one our most difficult clinical challenges,” said Rosenfield. “Peripheral arterial disease patients are in great need of better treatment options. This trial is an important step forward in evaluating a promising new therapy.”


About the Moxy drug-coated balloon

The Moxy balloon delivers an anti-proliferative drug to the artery in a single, 30-second inflation and then is removed from the body. The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with paclitaxel and a carrier molecule that facilitates rapid drug transfer upon inflation. This proprietary formulation allows delivery of a therapeutic drug dose to inhibit restenosis, while permitting restoration of the artery’s inner surface. The Moxy balloon is not approved for, or available for sale in, the United States.