Shockwave's energy-delivering angioplasty balloon for PAD receives CE mark

A rendering of the Lithoplasty balloon catheter, screenshot--Courtesy of Shockwave Medical

Medical device makers are scrambling to develop and sell advanced angioplasty balloons to treat peripheral artery disease. On the heels of the FDA's approval of a second drug-coated balloon for the condition, Fremont, CA's Shockwave Medical announced the receipt of a CE mark for its Lithoplasty balloon catheter which delivers lithotripsy, a pulsating form of mechanical energy, prior to performing angioplasty.

Shockwave CEO Daniel Hawkins told FierceMedicalDevices in an interview that commercialization of the product will not begin until the second half of 2015, for it is a common practice to conduct more studies following the receipt of a CE mark.

Shockwave says that in advanced cases of vascular disease, deep calcium deposits make treatment challenging, which is where their innovation comes into play.

"With Lithoplasty, even historically very challenging PAD patients with deep calcium can be treated effectively without significant injury to the vessel," said Dr. Marianne Brodmann of the Medical University of Graz, Austria, in the statement announcing CE-mark approval. That's because lithotripsy precracks 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.

In a prior interview Shockwave CEO Daniel Hawkins said lithotripsy 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. The pulsating form of energy 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 said.

A 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 reintervention within 30 days, the company says. Furthermore, all Lithoplasty patients achieved less than 50% residual stenosis with or without an additional adjunctive angioplasty procedure using a different balloon, and 87% achieved the goal using Lithoplasty alone, according to a prior release about the clinical trial results.

While the clinical goal was for the vessel to be more than halfway open after the procedure (or less than 50% residual stenosis), the average residual stenosis was 23%, meaning that on average, the vessel was more than three-fourths open after surgery, Hawkins said during the interview.

The company aims to join the ranks of Bard ($BCR) and Medtronic ($MDT) by obtaining FDA approval for its advanced balloon catheter, and said it is on track to do so in 2017, according to the release. However, Shockwave's device is distinct from those of the two industry bigwigs, because its balloon delivers energy, while the other two deliver drugs.

But both advances to angioplasty balloons for PAD have applications to the more risky and lucrative cardiology arena. Bard and Medtronic sell versions of their drug-coated balloons for the coronary artery in Europe, and Shockwave is testing a version of Lithoplasty for coronary vascular disease and aortic valve disease, Hawkins said.

- read the release

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