July 13, 2007 - Biotronik announced that it recently completed the enrollment of the ProLimus I First-In-Man trial to test the safety and efficacy of its ProGenic Pimecrolimus eluting coronary stent system.
Sixty-one patients enrolled at 5 sites in Belgium and Germany for the trial that will test the safety and clinical performance of the ProGenic Pimecrolimus eluting stent. Participating patients have single de-novo coronary artery lesions and will include patients with two-vessel disease. Clinical follow-up is conducted at 30 days, 6 months, 12 months and annually up to 3 years. At the 6-month follow-up all patients will undergo coronary angiography and intravascular ultrasound (IVUS) evaluation.
The primary endpoint of ProLimus I is a composite of major adverse cardiac events (MACE) at 6-month follow-up. Secondary endpoints include target vessel revascularisation (TVR), in-stent and in-segment binary restenosis, and late lumen loss (in-stent and in-segment) as measured by angiography.
The Biotronik ProGenic stent is comprised of four innovative elements: The PRO-Kinetic Cobalt Chromium Stent System; the PROBIO silicon carbide passive stent coating as a protective layer that reduces metal ion release and promotes endothelialization; a bioresorbable Poly-L-Lactic Acid polymer drug carrier; and the next generation in vascular drug technologies, Pimecrolimus. Following implantation of the ProGenic stent, drug and polymer is completely absorbed, leaving PROBIO as a long-term safety feature.
If results are favorable, the company will start enrollment of a randomized trial with approximately 320 patients in the first quarter of 2008.
For more information: www.biotronik.com