Johnson & Johnson has announced a deal to acquire cardiac implant developer V-Wave for a total of $1.7 billion. The agreement includes $600 million upfront and up to $1.1 billion in additional payments based on regulatory approvals and commercial milestones.
V-Wave’s flagship product is the Ventura interatrial shunt, designed for minimally invasive implantation in patients with heart failure with reduced ejection fraction (HFrEF). The shunt received FDA breakthrough device designation for heart failure in August 2019, followed by a second designation for pulmonary arterial hypertension the next month. It was granted CE mark approval in 2020.
Johnson & Johnson began investing in V-Wave in 2016. The company highlighted that the Ventura implant addresses a significant treatment gap between current medical therapies and more invasive cardiac replacement treatments, such as left ventricular assist devices (LVADs) and heart transplantation. J&J emphasized that the technology could benefit around 800,000 HFrEF patients in the U.S. each year, representing a significant market opportunity.
How The Ventura Interatrial Shunt Works
The Ventura interatrial shunt is implanted using a catheter that accesses the right side of the heart through the femoral artery. The catheter crosses the wall between the heart’s left and right atria and places the Ventura implant across the interatrial septum. The procedure is guided by fluoroscopy and echocardiographic imaging, including transesophageal echocardiography (TEE) and intracardiac echocardiography (ICE).
The shunt features a nitinol hourglass frame that anchors it to the fossa ovalis and prevents embolization. The device’s superelastic properties allow it to compress for delivery and then expand inside the heart. V-Wave notes that the shunt’s hourglass shape creates a venturi tube-like effect, enhancing blood transfer efficiency while allowing for a smaller device.
The Ventura shunt also uses expanded polytetrafluoroethylene (ePTFE) to limit tissue growth and prevent blockages. The latest design eliminates a one-way bioprosthetic valve present in earlier models to avoid lumen narrowing or blockage.
Future Prospects for V-Wave
The timeline for FDA approval of the Ventura implant remains unclear. The company’s RELIEVE-HF trial, which tested the shunt in patients with advanced heart failure, met its primary safety endpoint but did not show shunt-related benefits for the entire study population. Results indicated a 45% reduction in cardiovascular events among HFrEF patients, including a 52% reduction in hospitalizations for heart failure. However, the shunt was associated with increased cardiovascular events in patients with heart failure with preserved ejection fraction (HFpEF).
Dr. Gregg Stone, a principal investigator of the study, described the findings as “groundbreaking” for heart failure treatment, noting that the shunt showed significant benefits for HFrEF patients but was not suitable for HFpEF patients.
The acquisition is set to be completed by the end of 2024, with V-Wave becoming part of Johnson & Johnson MedTech’s Cardiovascular portfolio. Michael Bodner, President of J&J Medtech Heart Recovery & Intravascular Lithotripsy, will oversee the V-Wave team.
Dr. Neal Eigler, CEO of V-Wave, expressed confidence that Johnson & Johnson MedTech will effectively advance V-Wave’s technology to benefit patients. He praised the V-Wave team for their commitment and looked forward to further advancements in cardiovascular disease treatment.