The Lithoplasty system from Shockwave Medical
Peripheral artery disease, where plaque builds up in arteries in the legs and in other places preventing blood flow is usually treated using balloon angioplasty and stents, if a procedure is called for.
Now, one California startup is hoping to provide another option to physicians who can use the device to either replace current treatments or use it in conjunction with them. Fremont-based Shockwave Medical announced Friday that the Food and Drug Administration has cleared its Lithoplasty System for use in peripheral artery disease. One in 20 Americans over the age of 50 has PAD, according to the Department of Health and Human Services.
The device combines lithotripsy — which uses sound waves to break up calcium and is often used to treat patients with kidney stones — with the commonly used angioplasty balloon catheter.
“Lithoplasty is a unique approach that allows us to successfully treat these diseased vessels using a device built on a familiar balloon catheter platform, while minimizing the risk of vessel injury, including dissections that require stenting or other additional interventions,” said Daniel Hawkins, co-founder, president and CEO of Shockwave Medical, in an email forwarded by a representative.
Hawkins believes that his company’s technology spares soft tissue in the way current treatments cannot especially for arteries that are severely calcified
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Founded in 2009, Shockwave Medical has raised $62.9 million so far from the following investors – Sofinnova Partners, Venrock, RA Capital, Deerfield, Sectoral Asset Management, Ally Bridge Group, and two unnamed large-cap strategic investors. This includes a $40 million venture capital round raised in May 2015.
Hawkins wrote that the company will have a limited commercial launch next year of the device and plans to begin a global randomized trial to gather further clinical data on the benefits of Lithoplasty treatment. Reimbursement is available under existing codes, however, new technology has a steep hill to climb in terms of adoption these days, so gathering more data on benefits is prudent.
Hawkins declined to comment on whether the new device will be cheaper that existing treatments for PAD. And those treatments are made by the likes of Boston Scientific, Medtronic and C.R. Bard.
“Since this device can be used as either a standalone therapy or in conjunction with other technologies used in calcified arteries, it is simultaneously competing and complementary, depending on the specifics of individual patients and physician practice,” Hawkins believes.
In fact, he contends that although the device was used as a standalone therapy in the company-sponsored clinical trial, the Lithoplasty system can actually make drug coated balloon treatments — such as the ones made by Bard and Medtronic — more effective.
“In literature, it has been noted the drug coated balloons have sub-optimal results in severely calcified lesions,” Hawkins pointed out. “This technology may support broader use of DCB in these difficult-to-treat lesions.”
Photo: Shockwave Medical
