REFLOW MEDICAL


Associated tags: Physician, Medicine, Cardiovascular disease, Medical Devices, Health, Cardiology, Pharmaceutical industry, MD, Safety, Patient, Bare, MS, Clinical Trials, FDA, Trial of the century, Research, FACC, Intervention, Medical device, Health Technology

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.