Danvers, MA-based Abiomed announced that the Impella 2.5, Impella CP and Impella 5.0 heart pumps received approval from India’s Central Drugs Standard Control Organization for use during high-risk percutaneous coronary intervention, cardiogenic shock, and other reduced left ventricular function conditions.
The first patient was treated with the Impella 2.5 heart pump at Fortis Escorts Heart Institute in New Delhi. Ashok Seth, MD treated an 86-year-old man who was high risk for heart surgery and presented with severe, recurrent chest pain and multiple co-morbidities. A diagnostic catheterization demonstrated blockages of more than 90% in three left coronary arteries as well as distal disease. Dr. Seth performed a Protected PCI procedure including atherectomy with Impella 2.5 support. The patient was weaned off support and after three days was discharged.
“Abiomed is committed to expanding access to our heart recovery products around the world. We are moving forward to establish Heart Recovery Programs in India, starting with limited centers of excellence in New Delhi and Jaipur,” said Michael R. Minogue, president, chairman, and CEO of Abiomed. “We are proud to be the first Heart Recovery Program in India,” said Dr. Seth, chairman, Fortis Escorts Heart Institute and Head, Cardiology Council, Fortis Group.
