iVascular SLU has received approval for selling its coronary and peripheral products in India. Therefore, the company’s coronary drug-eluting stent, coronary dug-coated balloon, as well as its peripheral drug-coated and stents are now available for sale on the Indian subcontinent.
The approved devices include the Angiolite, which a press release describes as a coronary drug-eluting stent featuring exclusive coating nanotechnology “TransferWise” that yields a multilayer thin biocompatible coating. The press release states that the safety and efficacy of the stent for the treatment of patients with de novo lesions were confirmed by an optical coherence tomography (OCT) study – ANCHOR. Results of this study were published by Rishi Puri (Quebec Heart and Lung Institute (IUCPQ), UL, Canada) and colleagues in Catheterization and Cardiovascular Interventions.
The other approved devices are:
- Essential, a coronary drug-coated balloon
- Luminor, a peripheral drug-coated balloon
- iVolution, an open-cell, self-expanding (SE) nitinol stent indicated for femoral and popliteal arteries
- Restorer, a CoCr peripheral stent system, indicated for peripheral arteries.
According to the press release, iVascular proprietary coating nanotechnology, that guarantees drug’s stability, prevents from particles loss during navigation, and enhances fast and complete paclitaxel transfer to the vessel wall.
Lluis Duocastella, iVascular chief executive officer, comments: “ “iVascular product portfolio was created with the latest technologies to improve patient’s outcomes and provide physicians with the solution for the challenges that they’ve meet daily. We are excited to expand our presence furthermore into Asian market.”