The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to … continue reading “SELUTION SLR Coronary Sirolimus DEB Study: First US Patient Enrolled”
Clinical Studies/Trials
Breast Cancer EU Study Patients for CairnSurgical BCLTM System
CairnSurgical, Inc., an innovator striving to make breast cancer surgery more precise, has announced that the first patients have been … continue reading “Breast Cancer EU Study Patients for CairnSurgical BCLTM System”
First Patient Receives Fully Implanted Acclaim® Cochlear Implant in Envoy Medical Early Feasibility Study
Envoy Medical® Corporation tells us the first patient has been enrolled and implanted in the Acclaim® Cochlear Implant early feasibility … continue reading “First Patient Receives Fully Implanted Acclaim® Cochlear Implant in Envoy Medical Early Feasibility Study”
First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation
Swiss company Argá Medtech has begun enrollment in a First-in-Human Clinical Trial of its CSE Ablation System in the treatment … continue reading “First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation”
First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval
MedAlliance’s SELUTION SLR™ drug-eluting balloon (DEB) has received FDA Investigational Device Exemption (IDE) approval, making it the first limus DEB … continue reading “First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval”
First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™
Foldax®, Inc. says the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of … continue reading “First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™”
Study Shows Promise for Next-Generation Cardiac Ablation Tech
Argá Medtech’s next-generation non-thermal cardiac ablation system shows promise in improving precision, speed and flexibility in treating atrial fibrillation, says … continue reading “Study Shows Promise for Next-Generation Cardiac Ablation Tech”
Archimedes Effective in Guiding Sampling of Cancerous Peripheral Lung Lesions
A newly published global multicenter study demonstrates the effectiveness of the Broncus Medical, Inc. Archimedes Virtual Bronchoscopic Navigation (VBN) System … continue reading “Archimedes Effective in Guiding Sampling of Cancerous Peripheral Lung Lesions”
Tibial Neuromodulation for OAB: First Patient Implants
Medtronic plc says the first patient implants in the TITAN 2 pivotal study will evaluate the safety and efficacy of … continue reading “Tibial Neuromodulation for OAB: First Patient Implants”
LimFlow Completes Enrollment in PROMISE II Pivotal Trial
LimFlow SA tells us that it has completed patient enrollment in the pivotal trial of the LimFlow System for chronic limb-threatening … continue reading “LimFlow Completes Enrollment in PROMISE II Pivotal Trial”
Real-World Study Support for PROPEL® Sinus Implant
Patients receiving PROPEL® following endoscopic sinus surgery exhibited statistically significant lower healthcare resource utilization over a postoperative period of 18 months. … continue reading “Real-World Study Support for PROPEL® Sinus Implant”
Continuous Aspiration Thrombectomy with Penumbra Indigo® System CAT™RX Safe and Effective Says New Study
Success for Penumbra Inc.’s Indigo® System CATTM RX Catheter in a newly reported study. The device met the primary endpoint and demonstrated high rates of blood clot … continue reading “Continuous Aspiration Thrombectomy with Penumbra Indigo® System CAT™RX Safe and Effective Says New Study”
Promising Study Outcomes for X-Tack® Endoscopic Tacking System
Study demonstrates high success rates, ease of use, and economic value in the treatment of GI defects. Background Removal of … continue reading “Promising Study Outcomes for X-Tack® Endoscopic Tacking System”
SMART Medical’s G-EYE® Balloon Beats ENDOCUFF VISION® in Colon Adenoma Detection Study
The Adenoma Detection Rate (ADR) was higher for the G-EYE® balloon than for the EndoCuff Vision (ECV) attachment, says a new … continue reading “SMART Medical’s G-EYE® Balloon Beats ENDOCUFF VISION® in Colon Adenoma Detection Study”
Enrollment Complete in Tria™ Biopolymer Valve Study
The novel TRIA™ surgical aortic heart valve from Foldax®, Inc. has completed enrollment in its U.S. early feasibility study. Background Foldax … continue reading “Enrollment Complete in Tria™ Biopolymer Valve Study”
First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve
Based in Eindhoven, Netherlands, Xeltis is a clinical-stage developer of advanced polymer-based restorative cardiovascular devices. The company has now announced … continue reading “First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve”