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Elixir Medical Announces Successful Completion of First-In-Man Study Enrollment for Fully Bioresorbable Drug Eluting Coronary Scaffold System


11/2/2011 9:48:47 AM

Sunnyvale, CA —November 2, 2011—Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has successfully completed enrollment for a 15-patient First-In-Man clinical study for its fully bioresorbable drug eluting system, the DESolve™ Myolimus Eluting Bioresorbable Coronary Scaffold System. Initial clinical findings from this study will be presented at the 23nd Annual Transcatheter Cardiovascular Therapeutics (TCT) evening satellite symposium on Monday, November 7th 2011 in San Francisco, California.

The DESolve I Clinical Study is a non-randomized trial to study the safety and performance of the DESolve™ Myolimus Eluting Bioresorbable Coronary Scaffold System in patients with single, de novo native coronary artery lesions. Patients will be followed-up with angiographic, IVUS (Intravascular Ultrasound), OCT (Optical Coherence Tomography), and clinical assessments at 6 months and thereafter at yearly intervals for 5 years. The DESolve scaffold, made from a proprietary poly-L Lactide (PLLA)-based polymer, provides support to the artery while delivering the anti-proliferative drug, and is designed to bioresorb in the body within 1-2 years. The 15 patients were enrolled in Europe and New Zealand. Six months angiographic follow-up has commenced and will be completed in the first half of 2012.

“Bioresorbable drug eluting scaffold technology that does not leave a permanent metallic implant behind is clearly emerging as the next wave of advancement in interventional cardiology. Elixir Medical’s DESolve scaffold has the potential for returning diseased coronary vessels to their original, de novo state,” said Stefan Verheye, MD., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and Principal Investigator of the DESolve I Study. “Having used the scaffold system and observed its impressive performance, I am excited about the positive impact this novel technology may hold for our patients.”

“Fully bioresorbable scaffolds for the treatment of diseased heart vessels have always been considered the breakthrough frontier in interventional cardiology therapies, and Elixir Medical is committed to becoming a leader in the development of such innovative products,” said Motasim Sirhan, President and CEO of Elixir Medical. “Bringing the advanced DESolve™ technology to the clinic reaffirms our continued dedication to provide cutting-edge innovation for physicians to better the lives of patients worldwide.”

EVENING SATELLITE SYPOSIUM AT TCT 2011:

INNOVATING VASCULAR RESTORATION

On Monday evening, November 7th, 2011, TCT will be convening key opinion leaders in the interventional cardiology arena to discuss future generations of stent technologies and vascular restoration. Seating is limited and pre-registration is required.

Agenda:

• Overview of the Elixir Medical Program

• Clinical Experience with the DESyne™ and DESyne™ BD Novolimus-Eluting DES

• DESolve™ Bioresorbable Scaffold

Co-chairs:

• Alexandre Abizaid, M.D., Ph.D., of the Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

• Martin B. Leon, M.D., New York – Presbyterian Hospital / Columbia University Medical Center, New York, NY

Faculty:

• Peter Fitzgerald, M.D., Ph.D., Stanford University Hospital, CA

• John Ormiston, M.D., Auckland City Hospital, New Zealand

• Joachim Schofer, MD, PhD., Hamburg University Cardiovascular Center, Germany

• Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium

Location & Time:

• Hilton, San Francisco Union Square – 333 O’Farrell St., Continental Ballroom 6-9

• Monday, November 7th, 2011, 7:00 – 9:30 PM

About Novolimus and Myolimus

Novolimus and Myolimus belong to the powerful macrocyclic lactone class of drugs. This family of drugs is the most widely used for drug eluting stent applications. Novolimus, a metabolite of sirolimus, was developed internally by Elixir for use in site- specific therapies and has an established safety and efficacy profiles. Myolimus is a Novartis Pharma AG compound. Elixir has a license to Myolimus.

About Elixir Medical

Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company's next-generation drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.

Contact:

Vinayak Bhat, PhD

(408) 636-2006


Read at BioSpace.com


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