Phytis introduces world's first Double Coated Drug Eluting Stent

Phytis, a medical devices company based in Switzerland with production facilities in Germany (ISO 9001/EN46001 certified) and a distribution network in over 20 coun-tries, will introduce the world's first Double Coated Drug Eluting Stent during the Paris Course of Revascularisation (PCR) in Paris May 22-25, 2001.

Phytis designs, manufactures and markets minimally invasive medical devices since 1996. The main product today is the Diamond-Like Carbon (DLC) coated coronary stent in different sizes and lengths.

Background

In-stent-restenosis is the major problem in PTCA-procedures still today. The way to overcome this problem is to inhibit the process that leads to neointimal hyperplasia after stenting, the main reason for restenosis. Neointimal hyperplasia is caused by uncontrolled proliferation and migration of arte-rial Smooth Muscle Cells (SMC) into the lumen of the coronary vessel. The PTCA-procedure also causes denudation of the endothelial cell layer.

Before the endothelial layer is re-established the wound healing process remains un-finished. In the past, several drugs have been discussed by leading stent manufactures for drug eluting stents systems, some of them even have been tested in human clinical trials. Though it has been possible to stop SMC-proliferation, the cytotoxic effects of these drugs inhibited re-endotheliazation, which means antagonisation of the wound heal-ing process.

PHYTIS position today

Among the stents on the market today, the Phytis DLC coated stent in all probability has the lowest restenosis rate. "Almost daily we get statements from interventional cardiologists using Phytis stents that they don't see any or very few patients coming back for re-intervention" says Norbert Sass, the president and founder of the com-pany.

During the PCR meeting Dr. A. Salachas/ Athens/Greece will present a study with 96 patients/121 lesions/125 Phytis DLC coated stents with a restenosis rate of 4.1% af-ter 6 months angiographic follow-up.

Double Coated Drug Eluting Stent

In an attempt to eliminate re-stenosis, Phytis - the leading company in coating tech-nologies - has chosen to combine the drug 17-beta-estradiol with the existing DLC-coating, "which is a superior basis for endothelia cell growth" (Klein, et al, University of Mainz/Germany).

The 17-beta-estradiol eluting double coated stent concept unites the favourable qualities of the DLC-coating in terms of fast endothelial growths, inhibition of immune reaction and anti-allergic properties with the 17-beta-estradiol's ability of non-toxic inhibition of SMC proliferation and migration and acceleration of re-endotheliazation of the denudated coronary vessel wall.

Phytis Double Coated Drug Eluting Stent concept (patent pending) guaranties a fast wound healing process after balloon/stent injury with a dramatic reduction of re-steno-sis.

World Interventional Cardiologist leaders like Dr. Antonio Colombo/Milan, Italy and others will support this new stent concept. The first human visibility trials is estimated to start in the beginning of third quarter 2001.

Source: Phytis

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