Neovasc, at EuroPCR (21–24 May, Paris, France), reported initial data from open-label patient registries that are tracking the progress of refractory angina patients implanted with its Reducer device, which is a percutaneous device that is CE marked for the treatment of refractory angina.
Neovasc medical director Shmuel Banai, who is also associate professor of Medicine and Cardiology at Tel Aviv University’s Sackler School of Medicine and Director of Interventional Cardiology at Tel Aviv Medical Center in Israel, presented six-month follow-up data from 15 registry patients showing that their angina and physical disability were significantly improved after Reducer implantation.
Among other measures, patients were assessed on the Canadian Cardiovascular Society (CCS) grading scale. Despite the small size of this sample, the change in CCS scores was highly statistically significant compared to baseline (p=<.001). Patient subsets who received stress thallium and echo dobutamine testing also showed significant improvement with the Neovasc Reducer.
Banai commented, “We consider these results very encouraging. In these initial Registry patients, quality of life improved as average angina scores were substantially reduced, signalling a significant improvement in their ability to engage in daily activities without limiting chest pain. We also are seeing significant improvements in stress-related objective imaging measures, as well as trends suggesting that improvements in treadmill stress testing results will reach significance as our registry population continues to grow. Consistent with other experience to date, the Reducer appears very safe, with no reports of serious safety issues.”
The Neovasc Reducer is a percutaneous device designed to treat patients who suffer from refractory angina. The Reducer provides relief from symptoms by altering blood flow in the coronary sinus vein and thereby increasing perfusion of oxygenated blood to certain areas of the heart muscle. It is inserted using a percutaneous procedure that is similar to implanting a stent and takes less than 20 minutes.