Novel Treatment for Severe Aortic Stenosis on Track for FDA Nod

Results from Cardiawave’s Valvosoft pivotal study of 60 patients with severe symptomatic calcific aortic stenosis suggest treatment with the investigational noninvasive ultrasound therapy device achieved its primary endpoint, with nearly 92% of patients remaining free of major adverse cardiac events (MACE) at 30 days. Six-month data show use of the technology may also reverse or slow disease progression and improve quality-of-life.

Aortic stenosis is one of today’s most common and serious heart valve diseases, and one in dire need for nonsurgical treatment options. About 13% of Americans 75-years and older have aortic stenosis — a narrowing of the aortic valve opening. Over time, and in severe stages of the disease, calcium buildup can restrict blood flow to the body. Doctors might manage patients with lifestyle measures and risk factor reduction in the disease’s earlier stages. The standard of care for severe disease management is valve replacement surgery or minimally invasive transcatheter aortic valve implantation (TAVI).

“We estimate that over two million people are affected by the disease in Western Europe and the US, but less than a third are treated,” Olivier Pierron, Cardiawave CEO, told MD+DI. “One of the reasons is there are currently no alternatives to… surgical or transcatheter techniques.”

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Patients who are not candidates for surgery because of comorbidities or don’t want to undergo it, have no options. And the problem is likely to get worse as the 65-and-older population is expected to double in many of the world’s regions by 2050, he said.

How it works

Cardiawave’s noninvasive ultrasound therapy is unique, according to Pierron.

The technology uses a robotic platform to deliver imaging and treatment from outside of the patient’s body — the thorax. Valvosoft creates a focal point onto the valve defect with ultrasound imaging, and, in real time, allows the physician to screen and image the valve, locate the segment of the valve that is calcified and treat it.

The device delivers precise, focused, and high-intensity ultrasound to different valve areas, resulting in the formation of microscopic cavitation bubbles. The bubbles implode, creating shockwaves that mechanically fracture calcification imbedded in aortic valve leaflets.

These shockwaves soften the valve leaflets to restore leaflet mobility and to widen the opening of the aortic valve.

“… We do not decalcify the valve. We micro-fragment the calcification and soften the tissue,” said Pierron, who, according to a company press release, was hired earlier in 2024 for his expertise in developing and international commercialization of new medical technologies “at a crucial time in the company’s growth, following the announcement of positive clinical trial results.”

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Study results

Results from the prospective, multicenter, single-arm study presented in late October at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, are the most recent from Cardiawave. Of the 60 patients treated with Valvosoft, 40% were classified with very severe aortic stenosis and nearly a third were 90 years-old or older.

Key findings indicated that there were no incidences of stroke through six months. Compared to baseline, Valvosoft demonstrated the ability to reverse or slow disease progression, improving or stabilizing New York Heart Association class for 80.5% of patients. And patients’ quality-of-life — as indicated by responses to the Kansas City Cardiomyopathy Questionnaire score — improved on average 8.7 points over baseline.

Additionally, patient hemodynamics improved and by six months post-procedure, aortic valve area increased by 12% over baseline.

The company announced the study’s one-year results would likely be published in early 2025.

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Goal to transform heart disease management

Levallois-Perret, France-based Cardiawave was founded in 2014 with the aim of transforming cardiovascular disease management. Aortic stenosis has been the company’s focus for the past decade, according to Pierron.

The 60 patients treated with Valvosoft in the pivotal study bring to total number of severe symptomatic calcific aortic stenosis patients treated to 100, across 12 research centers in four European countries. The Lancet published a Cardiawave-funded study on 40 patients treated with the device in December 2023 concluding, “This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible.”

The company has secured over €22 million in funding since it began and is seeking an additional €15 million or more to get to the next level. The next level includes getting FDA approval and launching in the US, according to Pierron.

He said Cardiawave has been in discussions with FDA for the last three years. “We are expecting an answer from FDA before year end on the process and classification,” Pierron told MD+DI. “I cannot predict the outcome of the discussion with FDA, but this is a major focus of our strategy. Our mission is to enter the US market within two to three years maximum.”

Future indications

While the current focus is on using Valvosoft to treat severe aortic stenosis patients who are not surgical candidates, the technology might have applications in earlier stages of the disease — before the need for surgery and potentially to prevent progression.

The company also has a broader pipeline of alternative noninvasive therapy devices for cardiovascular disease management, but those applications are in too early a stage for Pierron to comment, he said.