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.
Vascular
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.
Endologix Completes ELEVATE IDE Clinical Study Enrollment
Endovascular stent graft study promises clinical results later this year
LimFlow US Feasibility Study Completes Enrollment
FDA allows study expansion and grants system “Breakthrough Device” status
Excellent Outcomes for TCAR Across Multiple Carotid Artery Disease Patient Populations
Updated TCAR data from Silk Road Medical’s ROADSTER 1 and 2 studies presented at VEITH Symposium
Portable Transcranial Doppler Technology Can Accurately Measure Early Strokes
Data Presented at 10th Society of Vascular and Interventional Annual Meeting
New Significant Outcomes from Mimics Study Announced at VIVA17
Seems the promise is realised as new clinical data suggests 3D stent technology outperforms straight comparator