SHERIDAN, WYOMING – November 10, 2024 – Shockwave Medical, a Johnson & Johnson MedTech company and a global leader in circulatory restoration, announced positive 30-day results from its DISRUPT BTK II study. This post-market study evaluated the safety and effectiveness of the Shockwave Peripheral IVL System in treating calcified peripheral lesions below the knee (BTK), including patients with critical limb-threatening ischemia (CLTI).
Addressing Peripheral Artery Disease with IVL Technology
Peripheral artery disease (PAD) affects over 8 million people aged 40 and older in the United States. PAD can significantly impact quality of life and increase the risk of heart attack or stroke. CLTI, the most severe form of PAD, affects nearly 2 million U.S. patients and carries a high risk of amputation and mortality.
Shockwave's Intravascular Lithotripsy (IVL) technology offers a groundbreaking solution for treating these challenging cases. IVL uses sonic pressure waves to break down calcified plaque, improving blood flow and patient outcomes.
DISRUPT BTK II Study Shows Promising Results
The DISRUPT BTK II study, a global, multicenter trial involving 250 patients with 305 lesions, demonstrated the safety and effectiveness of IVL in a complex patient population. Notably, 46% of patients had baseline wounds, 80% had CLTI, and 85% had 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. Venita Chandra, Vascular Surgeon and Clinical Professor at Stanford Health Care, who presented the study findings.
"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)."
Key Findings
- Procedural Success: 97.9% procedural success rate at 30 days, defined as less than or equal to 50% residual stenosis for all treated lesions without serious angiographic complications.
- Safety: 0.8% rate of major adverse limb events (MALE) or Post-Operative Death (POD) within 30 days of the procedure.
- Low Complication Rate: Angiographic complications were rare, occurring in only 1.9% of cases after IVL and 1.0% at the final procedure.
- Improved Limb Status: Within 30 days, 49% of treated limbs showed improvement in their Rutherford Category (RC) baseline.
- Enhanced Quality of Life: Patients experienced a statistically significant improvement in VascuQol scores, indicating a better quality of life.
Long-Term Follow-Up and Future Outlook
The DISRUPT BTK II study will continue to follow patients for up to two years to assess the long-term durability of these positive 30-day results.
Dr. Ehrin Armstrong, Interventional Cardiologist and Medical Director at Adventist Heart & Vascular Institute, expressed enthusiasm for the study's potential: "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 revolutionizing the treatment of cardiovascular disease with its innovative IVL technology. The company is committed to developing and commercializing products that improve patient outcomes and transform healthcare.
About Johnson & Johnson MedTech
Johnson & Johnson MedTech is a global leader in healthcare innovation, with expertise in cardiovascular, orthopaedics, surgery, and vision solutions. The company is committed to developing smarter, less invasive treatments and personalized solutions to profoundly impact health for humanity.