|A rendering of the Lithoplasty balloon catheter, screenshot--Courtesy of Shockwave Medical|
Fremont, CA's Shockwave Medical released clinical trial data at the Vascular Interventional Advances annual conference in Las Vegas that it says demonstrate the effectiveness of its investigational Lithoplasty balloon catheter at treating peripheral artery disease in patients with calcified lesions, which is the case in about two-thirds of people with the condition.
CEO Daniel Hawkins said in an interview that the catheter uses integrated lithotripsy--a pulsating form of mechanical energy commonly used to break up kidney stones--to "precrack" superficial and deep calcium so that the diseased vessel can properly expand during low-pressure balloon dilation (angioplasty), or the inflation of a catheter-based balloon at the site of a narrowed vessel or artery.
Hawkins said there is no balloon catheter on the market that delivers lithotripsy and his company aims to be the first. He said lithotripsy precracks calcium, but spares the vessel's healthy soft tissue. Delivering it is akin to rolling a boiled egg on a table to make it softer and more compliant, he said. Lithotripsy consists of extremely strong but infrequent waves, and enable the balloon to more evenly push on the vessel wall because the firmness of the target is more uniform once the hard calcium is precracked, the CEO explained.
The study of 35 patients with calcified vascular stenosis of the superficial femoral artery of the thigh and popliteal artery, located behind the knee, resulted in no major adverse events or re-intervention within 30 days, according to the release.
Furthermore, all Lithoplasty patients achieved less than 50% residual stenosis with or without angioplasty, and 87% achieved the goal using Lithoplasty alone. While the clinical goal was for the vessel to be more than halfway open after the procedure, the average residual stenosis was 23%, meaning that on average, the vessel the was more than three-fourths open after surgery, Hawkins said.
The company aims for CE mark approval in early 2015 and FDA clearance in the first half of 2017.
Hawkins said the study builds upon the company's coronary first-in-man study of Lithoplasty on lesions of the heart presented in September at the Transcatheter Cardiovascular Therapeutics conference in Washington, DC, for the company would like to use Lithoplasty in the coronary artery and aortic valve as well. The heart-version of Lithoplasty is the same that used in the peripheral vessels, but a little smaller, Hawkins said.
In January, Shockwave closed on a $12.5 million Series A financing lead by Paris-based Sofinnova Partners.
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Editor's note: This article has been updated to reflect an interview with the company CEO.