Vascular Concepts Group has announced satisfactory progress on its various clinical trials in Europe. These trials, covering three products, would enable the Group to successfully establish a presence in Europe.
The Group had commenced a 60 patient trial of its platinum coated stent, 'Propass' last year. The 6-month and 12-month results have been extremely useful. The reported 15 per cent restenosis rate and 10-11 per cent target lesion revascularisation (TLR) rate show considerable improvement over comparable historical data available for bare metal / passive coating stents. According to Dr. Thomas Ischinger, Principal Investigator and Professor of Cardiology, at Klinikum Bogenhausen in Munich, "The results are comparable, if not superior, to any other non-drug eluting stent or passive coated stent."
Vascular Concepts also recently completed a clinical study on Prograft, a covered stent graft, at Kardiologische Centrum in Frankfurt, Germany and Klinikum Bogenhausen in Munich, Germany. This trial focussed on patients who have had blockages after coronary artery bypass surgery, medically termed as Saphenous Vein Graft Lesions. Around 39 patients implanted with this stent showed a TLR of 17 per cent after one-year follow-up. These results are far superior to those reported with competitive products in a difficult subset of patients with Saphenous Vein Grafts.
The European clinical trials on Pronova (Euronova), the company's Sirolimus coated drug-eluting stent, commenced in March 2004 at Hospital Munich-Bogenhausen in Germany after obtaining unconditional approvals of the Freiburg IRB International, IRB of the Bavarian Medical Association of Munich and the Study Committee at Klinikum Bogenhausen.
As of July 30, 2004, a total of 76 stents had been implanted in 60 procedures. The interim results, disclosed by the hospital, are extremely encouraging. All 76 implantations were successful and interim angiographic acute results were excellent in all patients. According to the report made available by the hospital, the acute results with the Pronova stent have been most satisfactory. The report also adds that the Pronova Stent System exhibits high-level performance characteristics, especially crossability and flexibility.
According to Swaminathan Jayaraman, managing director, Vascular Concepts, the findings proves the versatility, reliability and world-class quality of our products. The tests that are in progress would ensure that we obtain the CE Mark approvals for marketing these products in Europe".
The Rs 35-crore Bangalore-based Vascular Concepts, is the principal operating company of the Vascular Concepts Group, engaged in the design, development and manufacture of endovascular medical devices that address the treatment of arterial diseases.
The Group develops its own technology, based on its extensive patent portfolio of Intellectual property, which includes 28 patents issued in the United States. The company develops the products/prototypes principally at the R&D centre in Bangalore, which is equipped with a world-class clean room (Class 10,000 & Class 100,000).
Vascular Concepts Group has announced satisfactory progress on its various clinical trials in Europe. These trials, covering three products, would enable the Group to successfully establish a presence in Europe.