Shockwave Lithoplasty System for Peripheral Artery Disease Earns CE Mark.
M2 PHARMA-January 7, 2015-Shockwave Lithoplasty System for Peripheral Artery Disease Earns CE Mark
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US-based vascular disease specialist Shockwave Medical Lithoplasty balloon catheters for the treatment of peripheral artery disease has earned CE Mark regulatory approval its, the company said on Wednesday.
Lithoplasty is a novel balloon-based technology that utilises integrated lithotripsy, a pulsatile mechanical energy commonly used to break up kidney stones, to disrupt both superficial and deep calcium and normalize vessel wall compliance prior to low-pressure balloon dilatation.
In advanced vascular disease, atherosclerosis becomes calcified deep inside the vessel walls, obstructing blood flow.
These deposits make current interventions challenging and prone to both procedural and long-term failure.Lithoplasty is designed to be naturally gentle on the soft, healthy, portions of the vessel, while remaining hard on difficult-to-treat calcified tissue.
Shockwave said its technology allows for low-pressure balloon dilatation, reducing the potential for soft tissue vascular injury, which is known to occur with current endovascular technologies.
CE Mark for Lithoplasty was supported by safety and utility clinical data from the multicenter Disrupt Pad study, which was presented in November 2014 at the Vascular Interventional Advances Annual Conference in Las Vegas, Nevada.
Early results demonstrated safe and effective dilatation of calcified stenosis with no acute failures, very favorable residual stenosis, no major adverse events and no restenosis out to 30 days.
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|Date:||Jan 7, 2015|
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