The V-Wave Ventura interatrial shunt is inserted into a patient’s heart. (Image courtesy of V-Wave)

Heart implant developer V-Wave has signed a deal with Johnson & Johnson that includes an upfront payment of $600 million plus up to $1.1 billion in additional payments depending on regulatory and commercial milestones.

V-Wave has developed its Ventura interatrial shunt for minimally invasive implantation in patients with heart failure with reduced ejection fraction (HFrEF).

The company announced in August 2019 that the FDA had designated the device as a breakthrough device for heart failure, and a second breakthrough approval for pulmonary arterial hypertension followed the following month. CE Marking for Ventura followed in 2020.

Johnson & Johnson began investing in V-Wave in 2016. In announcing plans to acquire the company, J&J said the Ventura implant “has the potential to close a significant treatment gap between guideline-directed medical therapies (GDMT) as first-line therapy and highly invasive heart replacement therapies, including left ventricular assist devices (LVADs) and heart transplants.”

The nitinol frame of the V-Wave Ventura interatrial shunt allows for folding for minimally invasive catheter insertion into a patient’s heart. (Image courtesy of V-Wave)

The technology “addresses an unmet need of approximately 800,000 patients diagnosed with HFrEF each year in the United States and represents a market opportunity for significant sustainable growth and impact,” the company added.

How the Ventura Atrial Shunt works

Using catheter access to the right side of the heart via the femoral artery, the catheter traverses the wall between the left side and the atrium of the heart (transseptal catheterization) and places the Ventura implant over the atrial septum.

The procedure is guided by fluoroscopy and echocardiographic imaging: transesophageal echocardiography (TEE) and/or intracardiac echocardiography (ICE).

The nitinol frame of the V-Wave Ventura implant expands itself as it exits the introducer sheath. (Image courtesy of V-Wave)

The Ventura shunt features a Nitinol hourglass frame that anchors it in the patient’s fossa ovalis and prevents embolization. The Nitinol frame (and the superelastic properties of this nickel-titanium alloy) allow the device to compress for catheter insertion and then expand as it exits the introducer sheath in the patient’s heart.

According to V-Wave, the shunt’s novel hourglass shape is “designed to create a Venturi-like effect from the high-pressure to the low-pressure atrium. This effect increases the efficiency of blood transfer and allows for a smaller shunt.”

Another important material of the Ventura shunt is expanded polytetrafluoroethylene (ePTFE), which surrounds the device to limit tissue growth and prevent blockages.

The V-Wave Ventura expands to anchor in the patient’s fossa ovalis. (Image courtesy of V-Wave)

The first generation of the Ventura atrial shunt had a disposable bioprosthetic valve, but the latest design eliminates this valve to avoid narrowing or blocking the lumen diameter, according to research funded by V-Wave and published in JACC: Cardiovascular Interventions And EuroIntervention.

What’s next for V-Wave

It is not clear when V-Wave will apply for or receive FDA approval for the Ventura implant.

The pivotal RELIEVE-HF trial in patients with advanced heart failure (HF) and any left ventricular ejection fraction (LVEF) at high risk for cardiovascular morbidity and mortality met the primary safety endpoint but failed to demonstrate a shunt-related benefit in the overall population studied, which included both patients with HFrEF and patients with heart failure with preserved ejection fraction (HFpEF).

“Shunt implantation in HFrEF patients was associated with a 45% reduction in cardiovascular events, including death, need for LVAD implantation or heart transplant, recurrent HF hospitalizations, and worsening outpatient HF events (P-Publishing study results in April 2024). “Favorable trends were observed for each of these types of cardiovascular events, led by a 52% reduction in HF hospitalizations. In contrast, shunt implantation in HFpEF patients was associated with an increase in these cardiovascular events.”

The V-Wave Ventura interatrial shunt in 1:10 scale (image courtesy of V-Wave)

This study “showed impressive results with the interatrial shunt in patients with HFrEF, but also definitively showed that this is not the right treatment for patients with HFpEF,” said Dr. Gregg Stone, one of the study’s principal investigators, calling the data “groundbreaking for the field of heart failure.”

The acquisition is expected to close by the end of 2024 and V-Wave will become part of Johnson & Johnson MedTech’s cardiovascular portfolio. Michael Bodner, President of J&J Medtech Heart Recovery & Intravascular Lithotripsy, will lead the V-Wave team.

Dr. Neal Eigler, CEO of V-Wave, said in J&J’s press release today announcing the deal that he was “confident that Johnson & Johnson MedTech is well positioned to ensure that V-Wave’s breakthrough ideas and technologies reach patients as quickly and effectively as possible.”

“I couldn’t be prouder of the V-Wave team and the commitment they have shown to achieve this milestone,” he continued. “We look forward to continuing to build a world where cardiovascular disease is prevented, treated and cured.”

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