Lutonix, Inc. Announces First Patient Enrollments in Three Separate Clini...( MINNEAPOLIS July 27...),Health

MINNEAPOLIS, July 27 /PRNewswire/ -- Lutonix, Inc., a privately held medical device start-up, today announced that patient enrollment is underway for its three simultaneous first-in-human clinical trials. The three studies are designed to test whether the proprietary Lutonix Drug Coated Balloon (DCB) Catheter is safe and effective in the treatment of vascular narrowing.

The PERVIDEO I Registry

The PERVIDEO I Registry is investigating the Lutonix Drug Coated Balloon Catheter for the treatment of coronary bare metal stent in-stent restenosis (ISR). The study will assess various safety and clinical endpoints over a two year period. Dr. Laura Mauri, Associate Physician and Director of Biometrics at Brigham & Women's Hospital in Boston, MA is serving as the Principal Investigator for the study along with Co-Principal Investigator Prof. Detlef Mathey of the Medical Center in Hamburg, Germany. The first patient was enrolled by Prof. Mathey.

"It is very exciting to have the PERVIDEO I study underway," said Dr. Mauri. "The scientific evidence collected from this investigation will support the initiation of large global trials in the near future," she added. Prof. Mathey states, "I have been involved in DCB research for several years now and I believe this technology, if formulated correctly, shows great promise for treating many types of coronary diseases, including bare metal ISR."

The LEVANT I Trial

The LEVANT I Trial is a randomized study designed to test the safety and efficacy of the Lutonix Drug Coated Balloon Catheter in preventing restenosis in the femoropopliteal arteries. Scheduled clinical and safety visits will assess endpoints out to two years.

Study Principal Investigator Prof. Dierk Scheinert, Director of Angiology at the Park-Krankenhaus in Leipzig, Germany states,
'/>"/>