Healthcare Industry News: Biosensors International Group
News Release - May 16, 2006
Xtent CUSTOM I Trial Shows Zero Restenosis, Favorable Late Loss Results at Eight Months
Principal Investigator Presents Results at EuroPCRPARIS--(Healthcare Sales & Marketing Network)--May 16, 2006 -- Xtent, Inc., the developer of the first customizable drug-eluting stent (DES), today announced eight-month follow-up results from its first-in-man CUSTOM I clinical trial at the EuroPCR meeting in Paris.
The CUSTOM I trial, which included 30 patients and completed enrollment in July 2005, demonstrated the feasibility and safety of in situ stent customization of diseased coronary artery lesions. The technology evaluated in the trial is Xtent's proprietary, fully customizable catheter system and stent, coated with a bioabsorbable polymer and the antiproliferative drug, Biolimus A9(TM), licensed from Biosensors International Group.
Principal Investigator for the trial, Professor Eberhard Grube, Director of the Heart Center in Siegburg, Germany, reported that at eight-month follow-up, there was zero percent restenosis.
"The CUSTOM I trial eight-month follow-up results compare very favorably with other first-in-man drug-eluting stent clinical trials," Dr. Grube stated. "The eight-month results showed no difference from the four-month measurements for late loss of lumen diameter, edge effect (narrowing at the stent edges), and binary restenosis. This is particularly impressive considering that the CUSTOM I trial included patients with more challenging lesions, including the longest lesions and smallest vessel diameters (2.6 mm) ever treated in a DES first-in-man trial."
Dr. Peter Fitzgerald, MD, PhD, Director, Cardiovascular Core Analysis Lab, Stanford University Medical Center, noted, "The IVUS (intravenous ultrasound) results demonstrate an impressively low volumetric obstruction comparable to Sirolimus DES platforms. This is an indication of the powerful effect of Biolimus A9 in inhibiting neointimal proliferation. These are excellent results."
According to Greg Casciaro, President and CEO of Xtent, "We are very pleased with the 8-month follow up results for CUSTOM I. The ability to customize stent length and diameter offers cardiologists the potential to completely and accurately cover lesions of many different sizes. The eight-month clinical results, as reported by Dr. Grube, validate the potential benefits of the Xtent system and bring us one step closer to our goal of offering the prospect of greatly improved treatment for many patients with coronary artery disease."
Xtent's CUSTOM II clinical trial, for which Dr. Grube is also Principal Investigator, is already well underway, enrolling 100 patients in eight different European cardiology centers. Inclusion criteria for the CUSTOM II trial allow for treatment of even more complex cases, including patients with either multiple lesions or long lesions which can be covered with up to 60 mm of total stent length.
About Xtent
Headquartered in Menlo Park, California, Xtent Inc. is a privately held developer of custom length drug-eluting stent (DES) systems for coronary and peripheral vascular disease. Xtent's customizable DES systems are designed to enable the treatment of single or multiple lesions of varying lengths in one or more vessels in a single catheter intervention. Founded in 2001, Xtent was incubated by The Foundry (Redwood City, CA) and incorporated in June 2002. Xtent has an extensive US and international patent portfolio covering a variety of delivery systems, stents, and coatings. The company has completed enrollment in its CUSTOM I clinical trial, and is now enrolling patients in the expanded CUSTOM II trial in multiple European centers.
Source: Xtent
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