Fast-growing startup company continues to execute key milestones and begins first in-market use of novel endovascular navigation technology CLEVELAND, May 4, 2020 /PRNewswire/ — Surgical navigation startup Centerline Biomedical, Inc. (Centerline), a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series clinical cases in the United States as […]
Peripheral/Endo
Cagent Vascular Announces FDA 510(k) Clearance for its Serranator Device for the Infrapopliteal Indication and Completion of its PRELUDE-BTK Clinical Trial Enrollment
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The Serranator device is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a […]
Intact Vascular Announces First U.S. Commercial Use of Tack Endovascular System® (4F) in Below-the-Knee Arteries
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System® (4F) in multiple sites across the United States. Notably the first FDA-approved vascular implant for below-the-knee post-angioplasty dissection repair, Tack® implants are designed to optimize balloon […]
FDA Grants NEXUS™ Aortic Arch Stent Graft System Breakthrough Designation
Endospan is Granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for […]
Proximo Medical Named Commercialization Partner for Elucid Bioimaging
CASTLE PINES, Colo., April 16, 2020 /PRNewswire/ — Today Proximo Medical, LLC, a business acceleration solution that addresses medical device commercialization challenges among startup and established medical device technologies looking to expand adoption in the U.S., announced a partnership with Elucid Bioimaging, a developer of diagnostic image analysis software used to assist in the detection and treatment […]
Tack Endovascular System® Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair
Intact Vascular’s Tack Endovascular System is a First-of-its-Kind Vascular Implant for Optimized Balloon Angioplasty Outcomes in Challenging CLI Patient Population WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack […]
Italian Vascular Access Group Recommends Use of SecurAcath on COVID-19 Patients
PLYMOUTH, Minn.–(BUSINESS WIRE)–Interrad Medical, a privately held medical device company, announces a new recommendation for use of SecurAcath on COVID-19 patients. The recommendation document was released on April 5, 2020 by a group of experts from the Long Term Central Venous Access Group (GAVeCeLT) and covers important aspects of vascular […]
Bluegrass Vascular Technologies Welcomes National Kidney Foundation’s Revamp of the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines for Vascular Access
Updated 2019 guidelines emphasize vessel preservation, aligns with the Surfacer® System’s “Don’t Go Left™” approach SAN ANTONIO, April 14, 2020 /PRNewswire/ — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, welcomes the recent publication of the 2019 Update to […]
MERIT MEDICAL RECEIVES TWO ADDITIONAL FDA BREAKTHROUGH DEVICE DESIGNATIONS
SOUTH JORDAN, Utah, April 06, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted two additional Breakthrough Device designations […]
Landmark Phase 3 VOYAGER PAD Study of XARELTO® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
XARELTO® has the potential to be the first anticoagulant in 20 years(i) to show a benefit in these high-risk patients Two major Phase 3 trials have evaluated XARELTO® vascular dose plus aspirin in treating patients with atherosclerotic disease RARITAN, N.J., March 28, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & […]
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