The US-based Medtronic Inc has successfully launched Driver, a coronary stent developed out of a cobalt alloy, by implanting the device in three coronary patients at Usha Mullapudi Cardiac Centre in Hyderabad on Thursday. The implant procedure of the new device was done for the first time in India by Dr B Chevalier, eminent interventional cardiologist from Paris.

Talking to Pharmabiz.com, Dr Chevalier said the product was launched only five months ago in Europe and 20,000 stents had been implanted already. He himself had performed about 120 implants of the new device so far.

He said about 10 patients had lined up for him for implants in Pune on Saturday and Sunday between two hospitals -- Ruby Hall Clinic and MHCTC (Military Hospital Cardio Thoracic Centre). Priced at around Rs 50,000, the new device was 50 % cheaper than the drug coated stents. Asked about its cost in France, he said it was totally free, though the patient was bound to pay the insurance premium.

Though both the drug-coated stent made of stainless steel and the new stent made of cobalt were life-long, it is a good compromise for the patients in terms of clinical outcome and cost. It was a good intermediate choice between drug-coated and uncoated stainless steel stents, Dr Chevalier said.

Asked whether any of his 120 patients had developed any complications, he said there was none. However, it was too early to say anything because the product was launched only five months ago.

Replying to a question on the standard of theatres and medical support in Indian hospitals, Dr Chevalier said they were as good as any foreign hospitals, maintaining very high international quality standards. The medical support at Usha Mullepudi was excellent, he said.

Dr Chevalier, who is an Advisor/ Consultant to Medtronic on the design and development of new medical devices, is president of the International Cardiology Group of the French Society of Cardiology and member of several committees on cardiology in France and Europe. He has 200 publications in international congresses and journals.

Launching the product in Hyderabad, Dr Narsing Rao, Medical Advisor to Medtronic, said, "The Driver stent has a very low profile and excellent trackability, flexibility and radial strength, which makes it uniquely suited for direct stenting, which means lower risk of complications, reduced radiation exposure and lower costs of the procedure."

The Driver stent's advanced cobalt alloy surpassed the limitations of stainless steel stents by making possible very strong, ultra-thin struts that offered flexibility and excellent vessel support, he said.

Dr Narsing Rao said about 35,000 to 36,000 ordinary stents and drug-coated stents were being used in India every year, with some 25 suppliers in the field. Asked whether the new device would phase out the stainless steel stents, he said it would be a combination of both for some time. Because of the price factor and added advantages, some companies would switch over to cobalt. But the design and manufacture of new stents would take time, he said.

Robert Young, International Marketing Manager of Medtronic, said coronary interventionalists had been asking for stents designed with thinner struts, Thin-strut stents tended to have lower profiles than thick-strut stents, making them easier to reach distally. In addition, recent clinical reports had suggested that strut thinness might affect restenosis rates, further moving the market towards thinner struts. The cobalt alloy had been chosen for its biocompatibility, strength, non-ferromagnetism and high resistance to fatigue and corrosion, he said.

"Research trials conducted on 300 patients in the US using Driver coronary stents indicate as low as 3 per cent Target Lesion Revascularisation (TLR) rate in patients with diseased coronary arteries. TLR is the need for a repeat angioplasty or artery bypass surgery following a stent implant. The TLR results of Driver coronary stent is comparable to some of the studies done with drug-coated stents," Robert Young said.

Asked whether the stent would get detached from the balloon, Robert Young said the new device had been developed taking into consideration all such drawbacks of earlier stents made of stainless steel.

Interestingly, the product has not been launched in the country of its origin so far, though Medtronic had filed an application before the UD FDA for its approval to launch the stent in US. The company currently is in the process of launching the device across several centres in India.