Medtronic Receives IDE Approval to Initiate Study of IN.PACT® Admiral® Drug-Coated Balloon for a New Indication in Patients with End-Stage Renal Disease
January 26, 2017 at 07:00 am
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Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a study of the IN.PACT® Admiral® drug-coated balloon (DCB) for a potential new indication in patients with end-stage renal disease. The randomized study will evaluate the IN.PACT Admiral DCB as a treatment for failing arteriovenous (AV) fistulas in these patients as compared to plain balloon angioplasty. The IDE approval enables Medtronic to initiate the study and gain safety and effectiveness data for the device in this investigational indication. Globally, more than 2.5 million patients with end-stage renal disease are undergoing dialysis, a procedure that filters waste and removes extra fluid from the blood when the kidneys are no longer healthy. AV access sites are used to provide hemodialysis to patients. Over time, thickening of the vessel walls limits the ability to use a dialysis access site, requiring repeat interventions, which increase health care utilization and reduce quality of care. Repeated procedures are also associated with high technical failure rates and reduced quality of life for patients. The IDE study will evaluate the safety and efficacy of the IN.PACT DCB for up to two years at approximately 30 sites in United States, Japan, and New Zealand. Principal Investigators include: Dr. Holden, Robert Lookstein, M.D., professor of radiology and surgery, vice-chair of interventional services, and medical director of clinical supply chain at Mt. Sinai Healthcare System, and Hiroaki Haruguchi, M.D., clinic director at Haruguchi Vascular Clinic. The study will aim to enroll 330 patients with a 2:1 randomization to either treatment with IN.PACT Admiral DCB or standard balloon angioplasty. The primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is major adverse events through 30 days. Additional endpoints include reducing access circuit related events including repeat procedures.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
Medtronic Receives IDE Approval to Initiate Study of IN.PACT® Admiral® Drug-Coated Balloon for a New Indication in Patients with End-Stage Renal Disease