FDA Board Votes Against Israeli Technology Bought by Johnson & Johnson for $600 Million

An advisory board to the US Food and Drug Administration (FDA) has voted unanimously against Israel’s Ventura technology, an implant designed for heart failure patients.

Ventura is the development of V-Wave, a startup company founded in 2009 by Dr. Asher Shmulevich, and acquired in 2024 by Johnson & Johnson for $600 million in cash with an option to increase the amount to $1.7 billion.

The hourglass-shaped implant is inserted into the body through a catheter and creates a small passage between the left and right atria of the heart to balance the pressure between them, improve the heart’s pumping efficiency and reduce symptoms such as shortness of breath and fluid buildup in the lungs.

After a 9-hour discussion, the 15 advisory board members agreed that the Ventura clinical trial was well designed and conducted well, but concluded that it did not achieve its primary goal of showing significant improvements in the health of patients with the implant, including a subgroup of patients with severe heart failure.

One committee member accused the researchers of “statistical acrobatics.”

Johnson & Johnson told media it was reviewing the committee’s recommendation, which called for more clinical data on the device.