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™”
Clinical Studies/Trials
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”
Positives for Broncus BTVA System
Broncus Medical, Inc., talks of the publication of results from the VAPORIZE study in the current issue of Respiration. The paper’s authors conclude that, … continue reading “Positives for Broncus BTVA System”
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”
CairnSurgical Breast Cancer Locator Trial Begins
The first patient has been treated in a U.S. pivotal trial of CairnSurgical’s Breast Cancer Locator (BCL) System. The system is … continue reading “CairnSurgical Breast Cancer Locator Trial Begins”
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.
App Boost for BioTech Businesses
Berlin-based Biotech networking company A-LabInsider has created an app that is a resource listing all academic life science labs in … continue reading “App Boost for BioTech Businesses”