Wave’s minimally invasive and implanted interatrial shunt is being assessed in a global, randomised, controlled and 500-patient pivotal IDE trial
Medical device firm V-Wave has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its interatrial shunt to treat patients with heart failure (HF).
The company is assessing the minimally invasive and implanted interatrial shunt in a global, randomised, controlled, double-blinded and 500-patient pivotal Relieve HF IDE trial.
V-Wave is recruiting advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline directed medical and device therapies.
V-Wave chief medical officer William Abraham said: “Despite decades of advances in therapy, heart failure patients continue to deteriorate, enduring disabling symptoms, having a poor quality of life, diminished exercise tolerance, and a markedly reduced life expectancy.
V-Wave minimally invasive and implanted interatrial shunt
V-Wave’s shunt is a miniature and biocompatible interatrial implant designed to offer a novel therapeutic approach for patients with chronic HF.
The shunt system is said to include a permanent implant placed during a minimally invasive cardiac catheterization procedure using advanced delivery catheter.
The device is intended to prevent episodes of elevated LAP, helping to offer symptom relief, decrease hospitalisation, increase exercise tolerance and improve quality of life.
Relieve HF is a prospective, multi-centre, 1:1 randomised, patient and observer blinded clinical study, with a shunt treatment arm and a non-implant control arm.
In October 2018, the company started the 500-patient patient study to evaluate the safety and efficacy of minimally invasive implanted interatrial shunt device to treat patients with NHYA Class III and ambulatory Class IV symptomatic HF.
The company plans to randomise 400 patients patients in the trial, and they will be blinded during follow-up for a minimum of one year to a maximum of two years.
“The V-Wave Shunt relieves excessive pressure in the left-side of the heart thereby reducing the build-up of fluid in the lungs, which is known to be the most common reason for HF hospitalizations and exercise limitation.”
V-Wave CEO Neal Eigler said: This breakthrough designation provides V-Wave with additional options for FDA communication that will facilitate collaboration, as well as a prioritized review of submissions and marketing applications.”