REFLOW MEDICAL, INC.


Associated tags: Physician, Medicine, Cardiovascular disease, Health, Pharmaceutical industry, Cardiology, MD, Medical Devices, Patient, Clinical Trials, Safety, Research, Bare, Spur, Principal

Locations: FLORIDA, UNITED STATES, NORTH AMERICA, CALIFORNIA, MS, EU, BRADENTON

Reflow Medical Completes Enrollment in the DEEPER REVEAL Clinical Trial

Retrieved on: 
Thursday, May 9, 2024
Surgery, Medical Devices, FDA, Clinical Trials, Health Technology, Cardiology, Biotechnology, Health, General Health, Lead, Knee, Clinical trial, Safety, Pi, FSVM, Scaffolding, Skin, FACC, Spur, Senior, Patient, Medicine, Cardiovascular disease, Multimedia, Trial of the century, Reflow soldering, RST, CLTI, Pharmaceutical industry

Reflow Medical, Inc. , a developer of innovative devices focused on cardiovascular disease, announces completion of enrollment in the DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Spur™ Stent .

Key Points: 
  • Reflow Medical, Inc. , a developer of innovative devices focused on cardiovascular disease, announces completion of enrollment in the DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Spur™ Stent .
  • Designated a Breakthrough Device by the FDA, the Spur is a unique clinical solution intended to provide stent-like results while leaving no metal behind.
  • The study enrolled 130 patients in over 35 clinical centers in the U.S.
  • Teo Jimenez, Senior VP of R&D at Reflow Medical, commented on completion of enrollment in the DEEPER REVEAL study : “We want to thank everyone who has partnered with us in completing this enrollment.

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

Retrieved on: 
Tuesday, January 16, 2024
Surgery, Medical Devices, Health, Health Technology, Cardiology, Mortality, Patient, European, Spur, Principal, MD, MDR, Multimedia, Bare, CLTI, RST, Risk, BTK, Quality of life, De novo, Division, Safety, Medicine, Amputation, CE marking, Medical University of Graz, DCB, Wound healing, Cardiovascular disease, Trial of the century, Physician, Pharmaceutical industry

Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System .

Key Points: 
  • Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System .
  • The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.
  • View the full release here: https://www.businesswire.com/news/home/20240116803175/en/
    The Bare Temporary Spur Stent System is a unique clinical solution known as Retrievable Stent Therapy, or RST.
  • The Bare Temporary Spur Stent System is a unique clinical solution intended to provide stent-like results while leaving no metal behind.

DEEPER OUS Trial Evaluating Reflow Medical’s Bare Temporary Spur Stent System Shows Positive Results at Six Months

Retrieved on: 
Tuesday, June 13, 2023
Health, Clinical Trials, Cardiology, Medical Devices, Medicine, Freedom, Senior, Calcification, Multimedia, Federal, Bare, MD, Patient, MALE, LINC, Research, Safety, POD, FESC, Angiology, Pharmaceutical industry, Telescopic sight, Medical device

Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System.

Key Points: 
  • Reflow Medical, Inc. announced the six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System.
  • In 38 patients with a total of 40 lesions treated with the Bare Temporary Spur Stent System, results demonstrated:
    a trend toward improved six-month patency in subjects without vessel recoil.
  • Prof. Zeller discussed these and other results in his presentation, “DEEPER OUS trial - Vessel Recoil Sub-study: Initial Insights.”
    The Bare Temporary Spur Stent System is designed to deliver a temporary stent with integrated radial spikes to the peripheral vasculature via a sheathed delivery system, for stent-like results while leaving nothing behind.
  • “We’re looking forward to continuing to see great results from the study.”
    The Bare Temporary Spur Stent System is for investigational use only.

Reflow Medical Introduces the coraCatheters™ Line and Expands into Complex Percutaneous Coronary Interventions (PCI)

Retrieved on: 
Friday, May 19, 2023
Medical Supplies, Health, FDA, Medical Devices, Hospitals, Health Technology, Cardiology, Catheter, University, Intervention, University of Washington Medical Center, FACC, Manatee Memorial Hospital, Multimedia, Doctor of Philosophy, Clinical professor, Associate, Movement, MS, PCI, Master of Science, Medical Center, Coronary artery disease, Research, Moyamoya disease, Pharmaceutical industry, Medical device, MD, Medicine

Reflow Medical, Inc. announced that it has received FDA commercial clearance for its coraCatheters™, a complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging lesions in percutaneous coronary interventions.

Key Points: 
  • Reflow Medical, Inc. announced that it has received FDA commercial clearance for its coraCatheters™, a complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging lesions in percutaneous coronary interventions.
  • View the full release here: https://www.businesswire.com/news/home/20230518005776/en/
    coraCatheters™ is a complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging PCI lesions.
  • The devices are the latest in the Reflow portfolio, which includes the Wingman™ and Spex™ Catheters.
  • (Graphic: Business Wire)
    The coraCatheters family of novel devices is the latest in the Reflow portfolio, which includes the Wingman™ and Spex™ Catheters.

First Patient Enrolled in Reflow Medical’s DEEPER REVEAL IDE Clinical Study

Retrieved on: 
Tuesday, November 1, 2022
Health, Clinical Trials, Cardiology, Medical Devices, Entrepreneurship, Intervention, IDE, Traction, CEO, FSVM, Skin, Advanced cardiac life support, Clinical trial, Hospital, Physician, Medicine, FACC, Safety, Bare, CLI, Cardiovascular disease, Technology, FDA, MS, Patient, Multimedia, ACV, Orange County, Solution, Trial of the century, Pharmaceutical industry, MD

Reflow Medical, Inc., a medical device company focused on cardiovascular disease, announces that the first patient was successfully treated and enrolled in the DEEPER REVEAL investigational device exemption (IDE) clinical trial (NCT05358353) at Advanced Cardiac & Vascular Centers (ACV) in Grand Rapids, Michigan.

Key Points: 
  • Reflow Medical, Inc., a medical device company focused on cardiovascular disease, announces that the first patient was successfully treated and enrolled in the DEEPER REVEAL investigational device exemption (IDE) clinical trial (NCT05358353) at Advanced Cardiac & Vascular Centers (ACV) in Grand Rapids, Michigan.
  • Were looking forward to enrolling our first patients in the DEEPER REVEAL study here in Florida.
  • Isa Rizk, CEO and Co-Founder of Reflow Medical, commented on enrolling the first patient in the DEEPER REVEAL study.
  • The DEEPER REVEAL trial continues to build on Reflow Medicals commitment to improving outcomes for patients suffering from critical limb ischemia, for which there are limited solutions to date.

Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment

Retrieved on: 
Wednesday, June 29, 2022
Health, Clinical Trials, Cardiology, Medical Devices, Reflow soldering, Patient, CEO, Research and development, Medicine, CLI, Spur, Â, Partnership, Principal, Cardiovascular disease, Medical University of Graz, Medical school, Ischemia, Safety, Physician, MD, Multimedia, Authorization, Pharmaceutical industry, EU, Research

Reflow Medical, Inc. , a California-based medical device company, has completed enrollment in the DEEPER LIMUS clinical trial (NCT04162418) to evaluate the Temporary Spur Stent System, a patented device designed to treat long, diffuse and severely calcified infrapopliteal disease.

Key Points: 
  • Reflow Medical, Inc. , a California-based medical device company, has completed enrollment in the DEEPER LIMUS clinical trial (NCT04162418) to evaluate the Temporary Spur Stent System, a patented device designed to treat long, diffuse and severely calcified infrapopliteal disease.
  • View the full release here: https://www.businesswire.com/news/home/20220628006094/en/
    The Temporary Spur Stent System is a novel device with a patented retrievable stent system.
  • On behalf of the team here at Reflow, we offer sincere thanks and gratitude for the partnership with Professor Brodmann and her team, commented Isa Rizk, CEO and Co-founder of Reflow Medical.
  • Reflow Medical, Inc. is a private company focused on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease.

Enrollment Completed in Reflow Medical’s DEEPER OUS Clinical Trial

Retrieved on: 
Thursday, May 12, 2022
Health, Medical Devices, General Health, Radiology, Clinical Trials, Cardiology, Biotechnology, Physician, Risk, Engineering, Medicine, FESC, Principal investigator, Spur, Patient, University, DCB, Radiology, CTO, Interventional radiology, Principal, Technology, Entrepreneurship, Auckland City Hospital, Development, MD, Cardiovascular disease, CEO, Pharmaceutical industry, Medical imaging, Research

Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the companys Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease.

Key Points: 
  • Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the companys Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease.
  • 106 patients have now been enrolled in the prospective, nonrandomized trial in multiple centers in Europe and New Zealand.
  • Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to approval of the Spur Stent System to treat patients, said Teo Jimenez, Vice President of Research and Development for Reflow Medical.
  • Reflow Medical, Inc. focuses on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease.

Reflow Medical Receives Approval in Japan for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease

Retrieved on: 
Thursday, October 8, 2020
Research, Surgery, Medical devices, Clinical trials, Cardiology, Biotechnology, Health, Other Science, Science, PMDA, Catheters, Reflow Medical, Inc., Century Medical, Inc., Chronic Total Occlusions (CTO) in Peripheral Artery Disease (PAD)

Reflow Medical, Inc., a California-based medical device company, announced that Japans Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman CTO Catheter.

Key Points: 
  • Reflow Medical, Inc., a California-based medical device company, announced that Japans Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman CTO Catheter.
  • Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in Japan.
  • View the full release here: https://www.businesswire.com/news/home/20201008005741/en/
    The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip.
  • Chronic total occlusions (CTO) of the lower extremities are found in 40% of symptomatic peripheral artery disease (PAD) patients.

FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System

Retrieved on: 
Thursday, January 9, 2020
FDA, Health, Cardiology, Medical devices, Medical technology, Medical devices, Medicine, Interventional radiology, Stent, Interventional cardiology, Medical equipment, Draft:Concept Medical, Dual therapy stent

Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).
  • We are extremely grateful to the FDA for their expedited designation of the Temporary Spur Stent System as a Breakthrough Device.
  • As Reflow continues to build on clinical evidence supporting the Temporary Spur Stent System, the company looks forward to furthering development in other clinical areas, based on the Spur technology platform.
  • The Temporary Spur Stent System is an investigational device only and is not currently approved for sale.