Tag: InfraReDx

B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter

Following Receipt of FDA Breakthrough Device Designation, Market Leading Global Organizations Strengthen their Cooperation to Navigate U.S. Regulatory Pathway BETHLEHEM, Pa., March 31, 2021 /PRNewswire/ — B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate […]

Results of the PROSPECT II Natural History Study Demonstrate High-Risk Plaques Identified by NIRS+IVUS Imaging are Linked to Future Coronary Events

PROSPECT ABSORB, a randomized substudy, showed treatment of high risk plaques with BVS is safe and associated with favorable long-term clinical outcomes compared to GDMT alone BEDFORD, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary […]

Infraredx, a Nipro Company, Announces FDA Approval of Expanded Label Claim for the Makoto™ Intravascular Imaging System

BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indications for use for its […]

Landmark Lipid-Rich Plaque (LRP) Study Results Demonstrate the Ability to Accurately Identify Patients and Plaques at Risk for Major Coronary Events

BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, Inc., a pioneer in intravascular imaging for mapping coronary artery disease, presented late-breaking clinical trial results for its landmark Lipid-Rich Plaque (LRP) Study today at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the […]

Infraredx to Present Results of the Lipid-Rich Plaque (LRP) Study at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 Scientific Symposium

BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, Inc., a pioneer in intravascular imaging for mapping coronary artery disease, today announced that results from the highly anticipated Lipid-Rich Plaque (LRP) Study have been accepted as a late-breaking clinical trial at the 30th Transcatheter Cardiovascular Therapeutics (TCT), […]

Infraredx Announces Launch of Makoto™ Intravascular Imaging System and Dualpro™ IVUS+NIRS Catheter in Japan

BURLINGTON, Mass.–(BUSINESS WIRE)–Infraredx, Inc., a pioneer in intravascular imaging for mapping coronary artery disease, today announced the Makoto™ Intravascular Imaging System, and accompanying Dualpro™ intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) catheter, is now available in Japan. The launch follows a […]

Infraredx Highlights Value of IVUS + NIRS for Detecting Lipid Core Plaque at the American College of Cardiology 67th Annual Scientific Session

BURLINGTON, Mass.–(BUSINESS WIRE)– InfraReDx, Inc., a pioneer in intravascular imaging for mapping coronary artery disease, today presented a poster at the American College of Cardiology (ACC) 67th Annual Scientific Session supporting the value of combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging technology to […]