Johnson & Johnson MedTech has officially welcomed V-Wave to its portfolio, marking a significant step in expanding its offerings for heart failure patients. The acquisition centers around V-Wave's Ventura Interatrial Shunt System, a novel implantable device designed to alleviate pressure on the left atrium and lungs in individuals suffering from heart failure with reduced ejection fraction (HFrEF). This move underscores Johnson & Johnson's commitment to addressing unmet needs in cardiovascular care.
The Ventura device, while not yet fully approved by the U.S. Food and Drug Administration (FDA), received the FDA's breakthrough device designation in 2019, highlighting its potential to provide more effective treatment for a life-threatening condition. The device is implanted via an interventional procedure using fluoroscopy and echocardiography guidance, anchoring to the patient's fossa ovalis to prevent migration or embolization.
RELIEVE-HF Trial Results
Data from the RELIEVE-HF trial, a randomized study evaluating the safety and efficacy of the Ventura device in heart failure patients, were presented at the American College of Cardiology (ACC.24) annual meeting. The trial included over 500 patients randomized to either receive the Ventura device or undergo a placebo procedure. Gregg Stone, MD, a professor at Icahn School of Medicine at Mount Sinai, presented the findings.
After a median follow-up of 22 months, results indicated that the Ventura device was safe and provided significant relief for patients with HFrEF. However, patients with heart failure with preserved ejection fraction (HFpEF) did not experience the same benefits. Stone emphasized the "very, very positive" impact on HFrEF patients in an interview with Cardiovascular Business.
Device Mechanism and Future Implications
The Ventura Interatrial Shunt System aims to improve hemodynamics in HFrEF patients by creating a controlled shunt between the left and right atria, reducing left atrial pressure and pulmonary congestion. This mechanism addresses a key pathophysiological component of HFrEF, potentially improving symptoms and quality of life for affected individuals.
Tim Schmid, executive vice president and worldwide chairman of Johnson & Johnson MedTech, stated that the Ventura device "offers tremendous promise for patients experiencing HFrEF" and has the potential to be the first device of its kind to market. Johnson & Johnson MedTech looks forward to collaborating with the V-Wave team to bring this innovation to patients.
