Medical Device News Magazine

Friday, March 31, 2023

Shockwave Confirms Consistent Outcomes for IVL in the Largest Prospective “Real World” Study of Patients with Heavily Calcified Peripheral Arterial Disease

Disrupt PAD III Observational Study Results Confirm Safety and Effectiveness of IVL in Patients with Complex Calcified Lesions

Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the final 1,373-patient cohort analysis from the Disrupt PAD III Observational Study (OS) again demonstrates consistent IVL outcomes in complex and challenging lesions across multiple peripheral vessel beds.

The study represents the largest prospective “real world” evidence supporting the treatment of complex, heavily calcified peripheral artery disease (PAD) with IVL. The final analysis was presented earlier today at VIVA22 in a late-breaking clinical trial session.

The key findings from Disrupt PAD III OS include:

  • IVL resulted in consistent reduction in the diameter of stenosis with no associated distal embolization, abrupt closure or thrombotic events at any time
  • IVL was the only calcium-modifying therapy used in most cases, required a limited need for adjunctive therapy tools (i.e., embolic protection), and had better results with appropriate IVL sizing
  • IVL results were comparable to the previously reported outcomes from the Disrupt PAD III randomized clinical trial (RCT) showing that IVL safely and effectively modifies calcium across multiple peripheral vessel beds

“These consistent results in a ‘real world’ population, combined with the recent long-term outcomes from the Disrupt PAD III RCT, reinforce the positioning of IVL as a reliable, potential first-line therapy for the treatment of large and diverse patient populations with calcified peripheral arterial disease,” said Ehrin J. Armstrong, MD, Medical Director, Adventist Heart and Vascular Institute, St. Helena, CA. “The significant amount of data on IVL continue to show both consistent efficacy and safety across the most challenging lesions, various peripheral vessel beds, and even in the most complex, high-risk patients.”

Disrupt PAD III OS is a prospective, multicenter, single-blind study of “real world” patients. The analysis looked at the total 1,373-patient cohort enrolled in the study from November 2017 to June 2021 at 30 global sites. Of the 1,531 lesions treated in the iliac, common femoral, superficial femoral, popliteal and infra-popliteal arteries, 90 percent presented with moderate/severe calcification, with an average calcified length of 115 millimeters. The use of IVL in these lesions resulted in a final residual diameter stenosis of 24 percent, similar to Disrupt PAD III RCT (22 percent). Patients also experienced minimal procedural complications, with only 0.7 percent and 0.2 percent experiencing final dissections (Type D-F) and perforations, respectively. Notably, there were no instances of embolization, thrombus formation, no reflow or abrupt closure.

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