LAS VEGAS, November 4, 2024 – Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the 30-day primary endpoint results of DISRUPT BTK II, a post-market study to assess the continued safety, effectiveness and optimal clinical use of the Shockwave Peripheral IVL System for the treatment of calcified peripheral lesions below the knee (BTK), including some of the most challenging patients with critical limb threatening ischemia (CLTI). The favorable results, which met both the primary safety and effectiveness endpoint, were presented in a late-breaking presentation at the annual Vascular InterVentional Advances (VIVA) meeting.
Peripheral artery disease (PAD) affects more than eight million people aged 40 and older in the United States.1 People suffering from PAD not only have impaired quality of life, but also increased risk of heart attack or stroke.2 CLTI is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S. It is associated with 40% major amputations at one year and a 50% mortality rate at five years,3 worse than most forms of cancer.
DISRUPT BTK II is a post-market, prospective, multicenter, core lab-adjudicated, single-arm study led by Venita Chandra, M.D., Vascular Surgeon and Clinical Professor, Division of Vascular Surgery, Stanford Health Care,† and Ehrin Armstrong, M.D., Interventional Cardiologist and Medical Director, Adventist Heart & Vascular Institute.† The study enrolled 250 patients with 305 lesions across 38 sites globally, representing a complex patient population with 46% of patients presenting with baseline wounds, 80% with CLTI, 70% with diabetes mellitus, 30% with chronic total occlusions (CTOs) and 85% with moderate-to-severe calcium.
“More and more patients with CLTI also present with end-stage renal disease, CTOs, advanced diabetes, or other comorbidities that impact their overall health and our ability to effectively treat their CLTI,” said Dr. Chandra, who presented the study. “These are the patients typically excluded from other studies. We already knew that IVL can reduce significant dissections and the need for provisional stenting over conventional percutaneous transluminal angioplasty in peripheral vessel beds. DISRUPT BTK II 30-day results add to this body of work with the use of IVL in the most challenging patients and showed that IVL offers a safe and effective treatment option that may improve patients’ quality of life and Rutherford Category (RC).”
The primary effectiveness endpoint of procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications was met with a rate of 97.9% at 30-days. The primary safety endpoint, the absence of major adverse limb events (MALE) or Post-Operative Death (POD) within 30 days of the index procedure, was met with a rate of 0.8%. Angiographic complications were rare, with only 1.9% occurring after IVL and 1.0% at the final procedure. Within 30-days, 49% of treated limbs had already improved from their RC baseline (p<0.001) and patients showed a statistically significant improvement in VascuQol scores (12.1 ± 4.0 at baseline to16.1 ± 5.1 at 30-days, p<0.001).
“Patients will now be followed in the study out to two years to assess the long-term durability of the compelling 30-day data in this difficult-to-treat patient population,” said Dr. Armstrong. “With both new IVL devices at our disposal and new data to interpret, I look forward to the additional analyses and learning about the optimal use of IVL to help improve outcomes in these difficult to treat patients.”
About Shockwave Medical
Shockwave Medical, part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at www.shockwavemedical.com.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com.Follow us at @JNJMedTech and on LinkedIn. Shockwave Medical, Inc. is part of Johnson & Johnson MedTech.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding the Shockwave Peripheral IVL System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Shockwave Medical, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.as a result of new information or future events or developments.
Footnotes
† Drs. Chandra and Armstrong are paid consultants for Shockwave Medical. They have not been compensated in connection with this press release.
1 https://www.nhlbi.nih.gov/health/peripheral-artery-disease
2 https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html
3 https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539
Media Contact:
Rachael Jarnagin
rjarnagi@its.jnj.com