Bangalore-based Vascular Concepts dealing with design, development and manufacture of endovascular medical devices has now commenced the clinical trials in Europe on “Pronova”, a state-of-the-art drug eluting stent after its successful round of study on Indian patients early this year.
The clinical trials in Europe have started under the aegis of Dr Ischinger, cardiologist, author and researcher who is the Principal Investigator for Euronova, the European trial programme of Vascular Concepts.
Pronova, the latest version in interventional cardiology product from Vascular Concepts’ has already been implanted in over 2500 patients in India and is making rapid strides in a market generally dominated by multinational companies.
The clinical studies, conducted on a patient base of 600 and carried out at leading hospitals in India, have shown that Pronova is safe, easy to deploy and considerably reduces the occurrence of restenosis (re-occurrence of blockages in arteries post stent implantation).
The participating hospitals were Ruby Hall Clinic, Pune, Jaslok, Hinduja and Lilavati Hospitals, Mumbai, Baroda Heart Institute, Baroda and Spandan Heart Institute, Nagpur. In addition, Escorts Heart Institute, New Delhi, has also completed a study on 120 patients under the aegis of Dr Ashok Seth, cardiologist and H-Interventional Cardiology for the hospitals.
The clinical studies were completed in February this year, and the results were announced at the CAD 2004 Conference in Mumbai by the Principal Investigators.
According to Dr. Ashok Seth, Escorts Heart Institute, “This is the product that India needs- a technologically superior product which is highly cost effective. Pronova has the potential to change patient care in this country and it is cost effective”.
“Drug eluting stents are a breakthrough invention in the treatment of coronary arterial diseases, The patient profile in India is rather complex because of a higher prevalence of diabetes and smaller coronary arteries,” informed Swaminathan Jayaraman, CEO, Vascular Concepts.
“Vascular Concepts was founded with the vision of bringing world class endovascular products to India at affordable prices. We are able to offer at a cost, which is 40 per cent lower than well-known international brands. It is this price-performance factor that makes our products extremely attractive, and has helped us garner a 25 per cent share of the Indian stent market,” he informed.
Bangalore based Vascular Concepts, a Rs.35 crore company is engaged in the design, development and manufacture of endovascular medical devices that address the treatment of arterial diseases.
The company develops its own technology, based on its extensive patent portfolio of Intellectual property, which includes 28 patents issued in the United States. It 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).