FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

The U.S. Food and Drug Administration today cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct...

Webinar Addresses ‘Hot Topic’

The recent OR Today webinar “Human Factors and Quality Testing for Device Reprocessing” was sponsored by Healthmark and eligible for one (1) continuing education (CE) hour by the State of California Board of Registered Nursing. The 60-minute webinar featured Jahan...

Nihon Kohden Introduces First Subscription-Based Pricing for Patient Monitoring, Neurology Products

Nihon Kohden, a U.S. market leader in precision medical products and services, has launched subscription-based pricing models for its patient monitoring and neurology products, the first in the industry to take such a step. The pricing models help align costs with...

Nihon Kohden Launches Life Scope SVM-7200 Series

Nihon Kohden has announced the launch of its Life Scope SVM-7200 Series vital signs monitor, a monitor designed for outpatient facilities and beds that traditionally are not continuously monitored. The monitor allows health care practitioners to quickly and easily...

Shockwave Medical Announces CE Mark Approval of its Lithoplasty System

Shockwave Medical has announced CE Mark regulatory approval for the company’s Lithoplasty balloon catheters for the treatment of peripheral artery disease (PAD).

Lithoplasty is a novel balloon-based technology that utilizes 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.

“Lithoplasty is a breakthrough that could revolutionize the treatment of peripheral artery disease – a common circulatory problem that can lead to serious complications, including amputation,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “With Lithoplasty, even historically very challenging PAD patients with deep calcium can be treated effectively without significant injury to the vessel.”

In advanced vascular disease, atherosclerosis becomes calcified deep inside the vessel walls, obstructing blood flow. These deposits make 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’s 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 (VIVA) 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.

“CE Mark approval for Lithoplasty in peripheral artery disease is an exciting milestone for Shockwave Medical and sets the stage for regulatory approvals in other geographies. We are also investigating applying this therapy to calcified coronary lesions – another important unmet clinical need,” said Shockwave Medical CEO and co-founder Daniel Hawkins. “Our initial clinical results in the coronaries are promising. Data presented at TCT 2014 from our first-in-man study demonstrated safety, tolerability, deliverability, and effectiveness.”

“We look forward to bringing this disruptive technology to patients with challenging calcified lesions in a number of vascular beds, as well as applying the technology platform to calcified valvular disease,” said Todd Brinton, M.D., co-founder of Shockwave Medical and Clinical Associate Professor of Interventional Cardiology, Stanford University.



Submit a Comment

Your email address will not be published. Required fields are marked *