The Resolute Integrity DES was the 1st device of its kind approved for use in patients with diabetes in addition to coronary artery disease, which makes up about ⅓ of all those with CAD.
With India hosting the 2nd largest population of diabetics in the world, the launch could be an important one for patients in the country as well as for Medtronic CEO Omar Ishrak’s ongoing commitment to expanding the company’s reach in emerging markets.
CAD patients with diabetes represent a difficult-to-treat population, as they often have smaller and more complex arteries, longer lesions and a higher rate of treatment failures, Medtronic told MassDevice.com in February when the device won FDA clearance.
Because of the complications arising from the co-morbidity, many patients are treated with open heart surgery, a more invasive option that requires extended hospital care and recovery time.
Although percutaneous interventions are often used for diabetic patients with CAD, no drug-eluting stent had previously been approved specifically for that population.
"With India having the 2nd highest diabetic population in the world, the Resolute Integrity coronary stent is set to gain wide acceptance in the country," Medtronic’s South Asia vice president and managing director Milind Shah said in prepared remarks. "The device combines deliverability, efficacy and safety, not to mention that it is the 1st DES approved for patients with diabetes."
First reported by Pharmabiz and independently confirmed by MassDevice.com, the moves are more evidence of Ishrak’s dedication to developing markets, including China and Russia.
India has played a big role in Medtronic’s emerging market strategy. Ishrak has called India the "biggest hole" in the company’s global reach, and earlier this month the company pledged $6 million for cardiovascular disease and diabetes research in the country.