Johnson & Johnson MedTech Announces One-Year Results from DISRUPT BTK II Trial Demonstrating Significant Limb Salvage Benefit of Peripheral IVL in CLTI Patients
Johnson & Johnson
Medical Device R&D and Manufacturer
Shockwave Medical
Cardiovascular Disease Treatment Device Developer
Johnson & Johnson Medical Technologies Releases PeripheralIVLSystemDISRUPT BTK IIOne-Year Study Results:CLTIThe patient benefited significantly from the treatment.
Recently, Johnson & Johnson Medical Technology (Johnson & Johnson MedTech) announced its Shockwave Peripheral Intravascular Lithotripsy (IVL) SystemDISRUPT BTK IIThe complete one-year follow-up results of the trial. This study targets infrapopliteal artery calcified lesions (BTK) multicenter, prospective, single-arm post-marketing study,Revealed for the First TimeIVLTechnology in Chronic Limb-Threatening Ischemia (CLTI) Long-term efficacy in patients, providing critical evidence for the treatment of complex peripheral arterial disease.
DISRUPT BTK IIThe trial was conducted by a clinical professor of vascular surgery at Stanford University Healthcare.Venita Chandraand Director of Medicine at the Adventist Heart and Vascular InstituteEhrin ArmstrongCo-lead,Globally38A research center recruited250Number of subjects, total treatments305Treat the lesion.The patient population has significant characteristics:
80%The subject was diagnosed withCLTI(Chronic Limb-Threatening Ischemia), where8.1%Amputation had occurred within one year prior to enrollment;
58.5%Wound present;
70%Suffering from diabetes;
30%Presence of chronic total occlusion (CTO）；
85%The lesion is moderately to severely calcified.
This study aims to evaluateIVLThe Safety and Effectiveness of the System in Real-World Complex Patients, with Particular Attention toCLTIImprovement in patients' risk of amputation, vascular patency, and quality of life.
DISRUPT BTK IIIn the trial,85%The case used Johnson & Johnson'sShockwave MedicalofJavelinPeripheralIVLCatheter. This catheter adopts a non-balloon design, releasing spherically diffused shockwave energy through a single distal emitter, directly targeting calcified lesions, especially suitable for sub-total occlusion. Its core advantages include:
Ultra-thin profile and long working distance:150Centimeter catheters can traverse extremely narrow vessels that traditional instruments cannot pass through.
Energy Forward Strategy: No Balloon Expansion Required"Clearing" the calcified segment to pave the way for subsequent treatment;
Low Complication Rate: The incidence of complications such as vascular perforation and dissection is significantly reduced compared to traditional rotational atherectomy or laser technology.
02 Core Results: Significant Benefits for CLTI Patients
Risk of Amputation Significantly Reduced
One-year follow-up showed,94.8%The subjects did not undergo major target limb amputation, and there was no baseline.CLTINo amputation records were found in the patients. InCLTIIn the subgroups, the amputation rate from baseline8.1%Reduce to1.2%`, indicating`IVLTreatment can effectively reduce the risk of limb loss in high-risk patients.
Low rate of target lesion revascularization
84.5%Participants avoided clinically-driven target lesion revascularization within one year (TLR），CLTIThis proportion reaches in the subgroup82.7%, DisplayIVLTreatment can reduce the need for repeat interventions.
Vascular Patency and Symptom Improvement
67.1%Subjects achieving long-term vascular patency;
75.5%Case of Rutherford Classification (RC) Improve at least1Level,48.7%The subjects were asymptomatic at one year (RC 0-1Level);
61.3%The wounds of the subjects healed or improved,CLTIThe wound healing rate in patients reached59.2%。
Effectiveness of Calcified Lesion Treatment
IVLThe system significantly improves vascular compliance by fragmenting the calcified ring through acoustic energy. Studies show that the postoperative residual stenosis rate decreased from the baseline.78%Decrease to26%, and97.9%Successful surgery (residual stenosis ≤50%), with a lower incidence of complications compared to traditional rotational atherectomy or laser technology.
InCLTIPatient (accounting for the enrollment80%) in,IVLThe treatment demonstrates greater clinical value:
Rutherford Classification Improvement: From Baseline80.1%Reduced to one year later25.1%, the patient's symptoms were significantly alleviated;
Primary Patency Rate:64%TheCLTIThe patient maintains vascular patency within one year;
Improvement in Quality of Life:VascuQoLAverage Improvement in Scores4.0±5.0（P<0.0001), patients' pain, mobility, and social participation significantly improved.
President of Cardiovascular Business, Johnson & Johnson Medical Technology, stated:“DISRUPT BTK IIThe results confirmed thatIVLTechnology inCLTITransformative role in patients. We are throughJavelinCatheter synergy with existing drug-coated balloons and stents to build 'calcification treatment-Vascular Repair-"One-stop solution for long-term maintenance."
2025Year9Month, Johnson & Johnson has been launched in EuropeJavelinCatheter, and plans to expand its accessibility through global channels. Meanwhile, the company continues to expandIVLIndications: In the future, it may advance into the field of coronary artery calcification to address chronic total occlusion (CTO), etc., unmet needs.
The research team will continue to follow up with patients for two years to evaluate the durability of the treatment effects and optimize treatment strategies for complex lesions.
DISRUPT BTK IIThe one-year results of the trial mark the entry into a new era of precision treatment for peripheral vascular calcification. Johnson & JohnsonIVLThe system, through innovative technology, forCLTIProvides hope for limb salvage in high-risk patients while reducing medical costs and social burden. With the expansion of the global market and the extension of indications,IVLTechnology is expected to reshape the treatment landscape in the field of vascular intervention.
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