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Devices Interventional

 News Release - April 5, 2017

First U.S. Patient Treated in Landmark Vascular Study of Lithoplasty(R) Technology

HARRISBURG, Pa., April 5, 2017 -- (Healthcare Sales & Marketing Network) -- PinnacleHealth CardioVascular Institute enrolled the first patient in the United States in a trial assessing the safety and effectiveness of a new type of approach for blockages in the leg artery.

DISRUPT PAD III is the largest ever multi-center randomized study to exclusively enroll patients with calcified peripheral artery disease (PAD). The objective of the trial is to assess the optimal therapy to dilate heavily calcified lesions by comparing the Shockwave Medical LithoplastyŽ System versus traditional angioplasty, with a primary goal of achieving less than 30 percent residual stenosis without the need for stenting. In addition, all patients who do not receive a stent will be treated with a drug-coated balloon. The trial will enroll 334 patients in up to 45 global sites. William Bachinsky, MD, FACC, medical director of vascular services at PinnacleHealth CardioVascular Institute, serves locally as principal investigator at PinnacleHealth.

Peripheral Artery Disease (PAD) is the narrowing or blockage of vessels that carry blood from the heart to the extremities. Caused by the buildup of plaque and calcium within the walls of arteries, PAD occurs primarily in the legs, but can be found in vessels throughout the body.

Balloon angioplasty involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage. Many patients do not respond well to angioplasty alone, with failure rates as high as 50 percent often due to hardened calcium within the wall of the artery.

"We are very excited to be the first to treat a U.S. patient in the global study of this cutting edge technology for patients with claudication or pain in the legs due to leg artery blockages," said Dr. Bachinsky. "The Shockwave Medical Lithoplasty device, if proven as a result of this clinical trial, will be a "game changer" in the treatment of patients with PAD, allowing for low pressure, controlled expansion of blocked artery and potentially less risk for internal tearing of the artery and need for implanting permanent metal stents."

Lithotripsy uses high-speed pressure waves to disrupt calcium and has been used for years in treating patients with kidney stones. Lithoplasty Technology delivers localized lithotripsy for the treatment of calcified arteries in patients with PAD. Built on an angioplasty balloon platform, each catheter incorporates multiple lithotripsy emitters activated with the touch of a button while the integrated balloon is inflated. Once activated, these emitters produce therapeutic sound waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque by creating a series of micro-fractures. Once the calcium has been disrupted, the vessel can be effectively dilated using low pressures thereby enabling even historically challenging PAD patients to be treated effectively and with minimal injury to the vessel.

The DISRUPT PAD III Study is one of more than 50 clinical trials for cardiovascular care currently underway at PinnacleHealth.

About PinnacleHealth System

PinnacleHealth System has been a leading provider of inpatient and outpatient healthcare services in central Pennsylvania since 1873. The 627-bed system has three acute care hospitals (Community General Osteopathic, Harrisburg and West Shore Hospitals) on four campuses (Community, Harrisburg, Polyclinic and West Shore) serving a five-county service area and supporting rural hospitals through affiliations and telehealth services. PinnacleHealth pursues innovative treatment options for the region through cardiac and cancer clinical trials, while offering convenient community services including medical home-certified primary care, urgent care, Magnet-recognized nursing excellence, emergency services, imaging, high-volume maternity care and a level III NICU, and workplace-based wellness services. PinnacleHealth includes a CardioVascular Institute and Cancer Institute, as well as a Bone and Joint Institute, Neurosurgery and Neurosciences Institute, and Spine Care Center that combine a multi-disciplinary approach to comprehensive spine, bone, joint, orthopedic and sports medicine services. PinnacleHealth is recognized for high-quality care with national and regional recognitions for volumes, outcomes and safety. For more information, visit pinnaclehealth.org.


Source: PinnacleHealth System

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