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IN.PACT Admiral Receives PMA Supplemental Approval
Medtronic announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). This is the first DCB that has gained approval to treat ISR in the U.S. FDA approval was based on ISR data from the IN.PACT Global Study compared to a standard percutaneous balloon angioplasty (PTA) control. Real-world data from the IN.PACT Global Study demonstrating safe and effective treatment of complex ISR lesions was first presented on the scientific podium at VIVA 2015. Data from this study were used to gain FDA approval of the ISR indication.
See more information on IN.PACT Admiral on Meddevicetracker.
IN.PACT Trial Data from Three Separate Studies Presented at VIVA
Medtronic presented a series of late-breaking clinical trial presentations at the Vascular Interventional Advances (VIVA) 2016 conference in Las Vegas, including three-year results from the pivotal IN.PACT SFA Trial, one-year results from the full clinical cohort of the IN.PACT Global Study, and results from the independent IN.PACT DEB SFA-Long Study.
The three-year outcomes from the IN.PACT SFA Trial were presented on September 19th by Prakash Krishnan, M.D., assistant professor of medicine and director of endovascular intervention at Mount Sinai Heart in New York. The results demonstrated the sustained, long-term clinical benefits of IN.PACT Admiral DCB compared to plain balloon angioplasty.
In a separate session on September 19th, Michael R. Jaff, D.O., medical director, Mass General Vascular Center at the Massachusetts General Hospital and professor of medicine at Harvard Medical School in Boston, presented new one-year results from the full clinical cohort of the IN.PACT Global Study. The results continue to underscore the consistent performance in both safety and efficacy for the IN.PACT Admiral DCB.
On September 20th, Dr. Antonio Micari of Maria Eleonora Hospital in Palermo, Italy presented results from an independent study evaluating treatment of long lesion lengths with the IN.PACT Admiral DCB. The results demonstrated durable safety and efficacy outcomes with the In.Pact Admiral PCB in patients with long femoropopliteal artery disease.
See more information on the IN.PACT on MedDeviceTracker.
Approval to Initiate Pivotal IDE Trial for Chocolate Touch Drug-Coated Balloon
QT Vascular announced that the U.S. Food and Drug Administration (FDA) has granted it conditional Investigational Device Exemption (IDE) approval. This approval allows the Company to begin enrolling patients in the pivotal study of its novel Chocolate Touch drug-coated balloon. The approval follows an extensive review by FDA of the Chocolate Touch technology including pre-clinical data, drug coating, bio safety, design features and clinical data.
The Chocolate Touch US pivotal study is a prospective randomized study in the United States, Europe, and New Zealand that will evaluate patients with disease in the superficial femoral and popliteal arteries in the legs. Patients will be randomized 1:1 to C.R. Bard’s Lutonix drug- coated balloon. The study will evaluate acute end points such as procedural successes and freedom from bail-out stenting, and long term endpoints such as patency and target lesion revascularization among others.
See more information on the Chocolate Touch on MedDeviceTracker.
First Implant Completed in Pivotal Study of GORE TAG
WL. Gore & Associates announced the first implant of the GORE TAG Thoracic Branch Endoprosthesis (TBE) in the pivotal study. The patient was enrolled by Himanshu Patel, MD, section head of adult cardiac surgery at the University of Michigan Frankel Cardiovascular Center and co-national principal investigator.
The objective of the study is to determine the safety and efficacy of the TBE in treating lesions of the aortic arch and descending thoracic aorta which includes dissection, trauma, or aneurysm. This pivotal study follows both an early feasibility study conducted in Zones 0-1 with the branch device in the brachiocephalic (BCA) or left common carotid (LCC) arteries and a feasibility study in Zone 2 with the branch device in the left subclavian artery (LSA). The pivotal study will include up to 40 sites across the U.S. that are expected to recruit up to 435 patients, treating all etiologies requiring proximal graft placement in Zones 0-2.
See more information on the GORE TAG Thoracic Endoprosthesis on MedDeviceTracker.
Staph ID/R Blood Culture Panel Launches in U.S. and EU
Great Basin announced the U.S. and European commercial launch of its Staph ID/R Blood Culture Panel, the Company’s first multiplex panel. This sample-to-result, automated panel benefits hospitals and laboratories by detecting, in about two hours, bloodstream infections caused by MRSA and other Staphylococcus species, enabling accurate, timely, and cost-effective diagnosis and treatment of patients. The panel detects the mecA gene, a major drug resistance marker that confers resistance to methicillin and other beta-lactams and creates the superbug MRSA. The assay is unique in its ability to distinguish Coagulase-negative Staphylococci (CoNS), which may not require treatment with antibiotics, from pathogenic Staphylococci.
The Staph ID/R Blood Culture Panel has received CE marking designation under the European Directive on In Vitro Diagnostic Medical Devices, extending the availability to facilities across 32 countries in the EU and Great Britain
See more information on the Staph ID/R Assay on MedDeviceTracker.
MRIdian System Launches in Japan
ViewRay announced that the National Cancer Center (NCC) in Tokyo, Japan has purchased a MRIdian System, the first system purchase in Japan. In mid-August, ViewRay announced that the company had received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the MRIdian System within Japan.
The ViewRay MRIdian System is a single medical device that combines a magnetic resonance imaging system for image guidance, with a cobalt-60 radiation delivery system. The system is designed so that the imaging and radiotherapy fields of view coincide, permitting imaging of the patient at the radiotherapy isocenter before and during treatment. These imaging and radiation delivery systems are designed to operate together as the ViewRay MRIdian System, for accurate, targeted administration of radiation therapy.
See more information on the MRIdian System on MedDeviceTracker.