REDUCER-I is a multi-centre, international, three-arm prospective and retrospective observational clinical study of Neovasc Reducer to treat refractory angina
Neovasc has announced positive interim results from the REDUCER-I clinical study, a multi-centre, international, three-arm prospective and retrospective observational study of its Neovasc Reducer to treat refractory angina.
The specialty medical device company said that the patients enrolled for the trial are left with no other treatment options including drug-therapy and represent a difficult-to-treat population.
In addition, the interim results comprised data from 241 patients enrolled in the study, with up to three years follow-up, making it the largest and longest duration Neovasc Reducer data set presented to date.
Stefan Verheye from Middelheim, Antwerp, Belgium said: “We believe the results from the REDUCER-I study demonstrate that for patients suffering from the debilitating effects of refractory angina, Reducer therapy is safe and offers a sustained improvement in symptoms.
“Today’s findings reinforce the results of the COSIRA study published in the New England Journal of Medicine and align with the current European Society of Cardiology Guidelines for the treatment of chronic coronary syndromes.”
Neovasc Reducer is a CE mark approved treatment for refractory angina
The Reducer is a CE mark approved treatment for refractory angina, as an alternate treatment to standard revascularisation or cardiac drug therapies.
Refractory angina is a painful and debilitating condition, characterised by the coronary arteries delivering inadequate supply of blood to the heart muscle. The disorder affects patients who typically lead severely restricted lives as a result of their disabling symptoms.
The Reducer is said to provide relief from angina symptoms by altering blood flow within the myocardium of the heart and increases the perfusion of oxygenated blood to ischemic areas of the heart muscle.
The device has not been approved for commercial use in the US, but was granted the FDA Breakthrough Device designation in October 2018.
The REDUCER-I study has reached the primary efficacy endpoint of improvement in chest pain, or angina, as measured by the Canadian Cardiovascular Society (CCS) grading system.
The subjects in the study experienced a 91% decrease in emergency department after treatment with Reducer, and less than 1% patients experienced a device or procedure related major adverse event.