Corporate
News release
TopBoston, MA – September 17, 2022 – Terumo Medical Corporation, a subsidiary of Terumo Corporation, a leading global medical device manufacturer, announces late-breaking data showing the safety and efficacy of radial to Peripheral (R2P) interventions with the R2P™ Misago® Self-Expanding Peripheral Stent in lower extremity endovascular interventions via a radial approach. The results were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation.
Presented by Dr. Yulanka Castro-Dominguez, MD FACC FSCAI of University Hospitals’ Harrington Heart & Vascular Institute Cleveland, OH, the study results showed that using a radial approach in treatment of complex lower extremity peripheral artery disease allowed 92.3% of patients to be discharged the same day. In addition, there were no serious access site complications for any of the patients enrolled in the study.
“In the invasive management of patients with peripheral arterial disease (PAD), the ‘radial first’ approach is beginning to gain momentum,” said Dr. Michael Martinelli, Chief Medical Officer of Terumo Medical Corporation. “Radial artery access has been shown to minimize bleeding and vascular complications, lessen mortality rates, reduce costs, and shorten length of stay compared to femoral access in patients undergoing percutaneous coronary intervention (PCI), and we are now seeing growing evidence for similar benefits in peripheral arterial intervention. Our study contributes significantly to this expanding body of evidence as it clearly demonstrates the safety and efficacy of radial access in PAD intervention.”
The study was a prospective, multi-center, core-lab reviewed, clinical endpoint committee (CEC) adjudicated, single-arm study aimed at evaluating the safety and feasibility of radial access when used in the treatment of complex lower extremity PAD. A total of 120 PAD patients with Rutherford classification 2 to 5, from eight medical centers from across the United States were enrolled from June 29, 2020 to June 24, 2021 and followed up to one year.
In the final analysis, the primary safety endpoint included evaluation of radial access related complications, to include: access site bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, radial artery occlusion, embolic stroke or transient ischemic attack (TIA). Based on CEC adjudication, primary safety events categorized as serious access site-related adverse events did not occur in any patient. Radial access was successfully achieved in 100% of patients.
Patients who received R2P Misago® Self-expandable Bare Metal Stent were later followed up to 12 months and the reintervention on the target lesion was required only in 2 patients.
The study was sponsored by Terumo Medical Corporation as part of its commitment to improving clinical outcomes and improving the patient experience. The company’s product portfolio, support for clinical trials and educational outreach to healthcare providers have provided an essential platform for the growth and success of radial access for coronary intervention – and as such, contributed significantly to improved outcomes for millions of patients worldwide.
Dedicated Terumo radial devices used in this study included: R2P™ Destination Slender Guiding Sheath, R2P Metacross® RX PTA Balloon Dilatation Catheter, R2P Crosstella® RX PTA Balloon Dilatation Catheter, R2P Misago® Self-expandable Bare Metal Stent and TR BAND® Radial Compression Device.
Indications
The R2P™ MISAGO® RX Self-expanding Peripheral Stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion length up to 150 mm.
Presented by Dr. Yulanka Castro-Dominguez, MD FACC FSCAI of University Hospitals’ Harrington Heart & Vascular Institute Cleveland, OH, the study results showed that using a radial approach in treatment of complex lower extremity peripheral artery disease allowed 92.3% of patients to be discharged the same day. In addition, there were no serious access site complications for any of the patients enrolled in the study.
“In the invasive management of patients with peripheral arterial disease (PAD), the ‘radial first’ approach is beginning to gain momentum,” said Dr. Michael Martinelli, Chief Medical Officer of Terumo Medical Corporation. “Radial artery access has been shown to minimize bleeding and vascular complications, lessen mortality rates, reduce costs, and shorten length of stay compared to femoral access in patients undergoing percutaneous coronary intervention (PCI), and we are now seeing growing evidence for similar benefits in peripheral arterial intervention. Our study contributes significantly to this expanding body of evidence as it clearly demonstrates the safety and efficacy of radial access in PAD intervention.”
The study was a prospective, multi-center, core-lab reviewed, clinical endpoint committee (CEC) adjudicated, single-arm study aimed at evaluating the safety and feasibility of radial access when used in the treatment of complex lower extremity PAD. A total of 120 PAD patients with Rutherford classification 2 to 5, from eight medical centers from across the United States were enrolled from June 29, 2020 to June 24, 2021 and followed up to one year.
In the final analysis, the primary safety endpoint included evaluation of radial access related complications, to include: access site bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, radial artery occlusion, embolic stroke or transient ischemic attack (TIA). Based on CEC adjudication, primary safety events categorized as serious access site-related adverse events did not occur in any patient. Radial access was successfully achieved in 100% of patients.
Patients who received R2P Misago® Self-expandable Bare Metal Stent were later followed up to 12 months and the reintervention on the target lesion was required only in 2 patients.
The study was sponsored by Terumo Medical Corporation as part of its commitment to improving clinical outcomes and improving the patient experience. The company’s product portfolio, support for clinical trials and educational outreach to healthcare providers have provided an essential platform for the growth and success of radial access for coronary intervention – and as such, contributed significantly to improved outcomes for millions of patients worldwide.
Dedicated Terumo radial devices used in this study included: R2P™ Destination Slender Guiding Sheath, R2P Metacross® RX PTA Balloon Dilatation Catheter, R2P Crosstella® RX PTA Balloon Dilatation Catheter, R2P Misago® Self-expandable Bare Metal Stent and TR BAND® Radial Compression Device.
Indications
The R2P™ MISAGO® RX Self-expanding Peripheral Stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion length up to 150 mm.
Important Safety Information
Do not use this device in patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients who are judged to have a lesion that prevents proper placement or deployment of the stent, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, or a lesion through which a guidewire cannot pass. This device should only be used by a physician who is familiar with, and well trained in percutaneous transluminal angioplasty (PTA) techniques, stent implantation, and transradial access.
RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.
About Terumo Interventional Systems
Terumo Interventional Systems (TIS), a division of Terumo Corporation, is a market leader in minimally invasive entry site management, lesion access, and interventional technologies. TIS offers a complete, solution-based product portfolio used in advanced coronary, peripheral and endovascular treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention, Peripheral Artery Disease and Embolotherapy. TIS combines innovative research and development with a deep market understanding to create a pipeline of industry-leading devices that deliver clinical value, economic benefit, and enhanced patient outcomes.
About Terumo Medical Corporation
Terumo Medical Corporation (TMC) is a subsidiary of Terumo Corporation, founded in 1972 as the United States expansion of our larger Tokyo-based parent. For nearly 50 years, TMC has continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve. TMC provides products and services across four divisions: Terumo Health Outcomes (THO), which provides healthcare systems with solutions designed to reduce care variation, improve quality metrics, minimize cost and maximize revenue; Terumo Interventional Systems (TIS), which offers solutions for entry site management and lesion access; Terumo Medical Products (TMP), which provides devices for injection and infusion therapy; and Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices.
About Terumo
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.