Treatment supported by evidence from multiple studies and Renal Denervation Position Paper from the European Society of Hypertension Background It’s … continue reading “Renal Denervation Back in Europe with ReCor Paradise™ Launch”
Vascular
FDA Breakthrough Device Status for Hancock Jaffe VenoValve®
Cardiac and Vascular device developer Hancock Jaffe Laboratories, Inc., tells us that the U.S. FDA has granted Breakthrough Device Designation status to … continue reading “FDA Breakthrough Device Status for Hancock Jaffe VenoValve®”
Japan Approves LimFlow Study
Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved LimFlow’s Clinical Trial Notification (CTN) for the Japanese cohort of the … continue reading “Japan Approves LimFlow Study”
Fourth FDA Breakthrough Device Award for Sirolimus DEB
The FDA has awarded MedAlliance breakthrough status for its SELUTION SLR™ sustained limus release Drug Eluting Balloon (DEB) catheter, in … continue reading “Fourth FDA Breakthrough Device Award for Sirolimus DEB”
FDA Clears Vetex ReVene Thrombectomy Catheter
Vetex Medical Ltd. tells us that the U.S. FDA 510(k) has cleared its the ReVene® Thrombectomy Catheter. Vetex expects to make the … continue reading “FDA Clears Vetex ReVene Thrombectomy Catheter”
FDA OKs ReCor Paradise™ Ultrasound Renal Denervation
ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
Penumbra’s Indigo® Cleared for Pulmonary Embolism
Penumbra, Inc. has announced U.S. FDA 510(k) clearance for expanded indication of the Indigo® Aspiration System, Lightning™ 12. Background Pulmonary embolism, … continue reading “Penumbra’s Indigo® Cleared for Pulmonary Embolism”
First Two Patients for SELUTION SLR™ Sirolimus Drug Eluting Balloon Study
The first two patients have been enrolled in the PRISTINE registry with MedAlliance’s SELUTION SLR™ 018 Drug Eluting Balloon (DEB) … continue reading “First Two Patients for SELUTION SLR™ Sirolimus Drug Eluting Balloon Study”
First Patient in SELUTION SLR™ Study for AV Fistula
MedAlliance has announced enrollment of the first patient in the SAVE* study utilizing their novel sirolimus-eluting balloon. The device is … continue reading “First Patient in SELUTION SLR™ Study for AV Fistula”
Promise for Emboliner™ Embolic Protection Catheter as Safepass 2 Study Completes Enrollment
Emboline™, Inc., developer of total embolic protection technology for transcatheter aortic valve replacement (TAVR), has announced completion of enrollment in its … continue reading “Promise for Emboliner™ Embolic Protection Catheter as Safepass 2 Study Completes Enrollment”
First Patient Enrolled in Coronary Mechanical Thrombus Aspiration Study
Penumbra, Inc., tells us it has seen enrollment of the first patient into a prospective, multi-center U.S. study to evaluate … continue reading “First Patient Enrolled in Coronary Mechanical Thrombus Aspiration Study”
Carotid Artery Disease Patients do Better with TCAR than Endarterectomy
Silk Road Medical Inc. has announced the presentation of real-world data from two studies into the treatment of patients with … continue reading “Carotid Artery Disease Patients do Better with TCAR than Endarterectomy”
Multiple Silk Road Medical TCAR Presentations at 2018 VEITHsymposium
One-Year results of SVS TCAR surveillance project will feature
FDA Clears Eximo Medical B-Laser™ Atherectomy System for Peripheral Artery Disease
Eximo Medical Ltd. says it has received U.S. FDA 510(k) clearance for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD)
First-in-Man Study Demonstrates Safety and Efficacy of SELUTION™ DCB in Long Lesions
Findings confirm the efficacy of the SELUTION sirolimus-coated technology
First Patient in Confirmatory Clinical Study of Nellix® EVAS system
A first patient has been treated in the EVAS2 IDE Confirmatory Clinical Study of the Nellix® EndoVascular Aneurysm Sealing system.