Contego Medical’s Neuroguard IEP System Receives FDA Approval for Carotid Revascularization
Raleigh, NC – October 15, 2024 — Contego Medical, a leader in developing innovative medical devices for cardiovascular procedures, announced the U.S. Food and Drug Administration's (FDA) premarket approval (PMA) of the Neuroguard IEP® System, a unique 3-in-1 carotid stenting system that combines a high-performance stent, an integrated dilation balloon, and integrated filter. The system streamlines the carotid stent procedure by reducing the number of steps and makes it safer by capturing emboli that traditional embolic protection systems do not.
Dr. Mitchell J. Silver Joins Contego Medical as Chief Medical Officer
RALEIGH, N.C., Aug. 5, 2024 -- Contego Medical, Inc. announced today that Mitchell J. Silver, D.O., FACC, FSVM, RPVI, a renowned interventional cardiologist and vascular medicine specialist, joined the team as Chief Medical Officer (CMO). He will play a pivotal role in shaping the company's clinical strategy and advancing the portfolio of carotid and thrombectomy products. His medical leadership and strategic guidance will help guide clinical development, regulatory affairs, and commercialization efforts for the upcoming launch of the Neuroguard IEP® System carotid stent delivery catheter, Neuroguard IEP Direct transcarotid revascularization system, and Excipio® peripheral thrombectomy devices.
Contego Medical Announces One-Year Outcomes From The Performance II Carotid Stent Trial
RALEIGH, N.C., Nov. 1, 2023 /PRNewswire/ -- Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at the annual VIVA (Vascular InterVentional Advances) multidisciplinary vascular education conference. PERFORMANCE II is a prospective, multicenter study evaluating the safety and effectiveness of the Neuroguard IEP® System in 305 patients at 40 clinical sites.
Contego Medical Announces Presentation of Results From Performance II Carotid Stent Trial at Viva23
RALEIGH, N.C., Oct. 30, 2023/-- Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced the completion of 1-year follow-up visits for patients in the PERFORMANCE II Carotid Stent Trial and the upcoming presentation of 30-day and 1-year results at the VIVA (Vascular InterVentional Advances) meeting.
Contego Medical Announces Start of Enrollment in Performance III Direct Transcarotid Access Stenting Trial
RALEIGH, NC, October 6, 2023 /PRNewswire/ -- Contego Medical, Inc. a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, today announced enrollment of the first patient in the PERFORMANCE III Trial. PERFORMANCE III is a prospective, multicenter trial aimed at further evaluating the safety and effectiveness of the Neuroguard IEP® Direct System, a carotid stent system designed for direct transcarotid access.
Contego Medical Completes Enrollment of the PERFORMANCE II Carotid Stent Trial
RALEIGH, NC, November 14, 2022 /PRNewswire/ -- Contego Medical, Inc. announced that enrollment of the PERFORMANCE II clinical trial has been completed. PERFORMANCE II is designed to evaluate the safety and effectiveness of the Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat clinically significant carotid artery stenosis while improving procedural safety through the integration of the stent, balloon and an embolic filter all in a single device.
Contego Medical Announces Hiring of Steve MacKinnon, Chief Commercialization Officer
RALEIGH, N.C., Feb. 10, 2022 /PRNewswire/ -- Contego Medical has announced that Steve MacKinnon has joined the organization as their Chief Commercialization Officer. Mr. MacKinnon is an accomplished senior medical device executive with significant commercialization experience, a track record of success, and a history of driving growth by building and managing highly motivated sales teams. In his role, Mr. MacKinnon will be responsible for launching a portfolio of innovative and state-of-the-art medical devices that will redefine the treatment of cardiovascular disease.
Contego Medical, Inc. announced receipt of CE Mark approval for the Neuroguard IEP®
RALEIGH, N.C., April 16, 2021/PRNewswire/ — Contego Medical, Inc., a leading developer of innovative cardiovascular devices, today announced receipt of CE Mark approval for the Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System).
Contego Medical Announces the Start of Enrollment in the PERFORMANCE II Carotid Stenting Clinical Trial
RALEIGH, N.C., June 15, 2020 /PRNewswire/ -- Contego Medical, Inc. today announced enrollment of the first patient in the PERFORMANCE II Trial evaluating the safety and effectiveness of the Neuroguard IEP® 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat clinically significant carotid artery stenosis while improving procedural safety through the integration of stent, balloon and filter technology all in a single device. The first patient was treated at University of North Carolina Rex Hospital in Raleigh, North Carolina by James Zidar, M.D., FACC, FSCAI.
Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
Raleigh, NC (December 07, 2018) -- Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection. Contego Medical is a medical device company developing and commercializing a suite of next-generation devices that address unmet needs in neurovascular, coronary and peripheral vascular disease.