Windtree Therapeutics (OTCQB:WINT) and Eleison Pharmaceuticals have announced positive results of a feasibility study using Windtree’s aerosol delivery system (ADS) to deliver Eleison’s inhaled lipid cisplatin (ILC) for lung cancer. In the study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in a phase 2 […]
Clinical Trials
Bluegrass Vascular’s pivotal Surfacer trial meets primary endpoints
Bluegrass Vascular Technologies today released preliminary results from the pivotal trial of its Surface Inside-Out access catheter system, touting that the trial met both its primary and secondary endpoints. The San Antonio-based company also said that it has completed enrollment in the SAVE-US trial, recruiting 30 patients across seven U.S.-based centers. “I’m quite encouraged by […]
Saluda Medical touts Evoke closed-loop SCS studies
Saluda Medical today released data from two studies of its Evoke ECAP-controlled closed-loop spinal cord stimulator. The Evoke SCS system is designed to measure the spinal cord’s response to stimulation and adjust on every pulse to maintain activation within the patient’s therapeutic window, the Australian company said. Results from both the Evoke and Avalon studies […]
Ancora Heart launches 2nd AccuCinch ventricular repair system feasibility study
Ancora Heart said yesterday that it launched a U.S.-based early feasibility study looking to evaluate its AccuCinch ventricular repair system intended for treating patients with reduce ejection fraction systolic heart failure. The first patient has already been enrolled in the study at UPMC Pinnacle Harrisburg by Dr. Hemal Gada and Dr. Mubashir Mumtaz, Santa Clara, […]
NuVasive touts submission of spine registry data to CMS
NuVasive Inc. (NSDQ:NUVA) said yesterday that it submitted its SpineTrack registry quality performance data to the Centers of Medicare & Medicaid Services. The data was submitted on behalf of healthcare providers at Southern Oregon Neurosurgical & Spine Associates (SONSA) for CMS’s merit-based incentive payment system, the San Diego-based company said. As a result of the submittal, […]
Philips touts Stellarex drug-coated balloon data
Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. Spectranetics won […]
Checkpoint Surgical touts nerve monitor study results
Checkpoint Surgical today announced the results of a study that called its handheld nerve monitor a safe and reliable alternative to existing technology for neural monitoring during surgery. The retrospective study compared the use of the Cleveland, Ohio-based company’s Checkpoint nerve stimulator/locator to Medtronic’s nerve integrity monitor for vagal, recurrent and superior laryngeal nerve monitoring […]
InVivo Therapeutics launches new neuro-spinal scaffold study
InVivo Therapeutics (NSDQ:NVIV) said today that it launched a new trial of its neuro-spinal scaffold, dubbed the INSPIRE 2.0 study, and that it has enrolled the first two patients into the study. The Cambridge, Mass.-based company won FDA approval to launch the new pivotal study of the device last March, after ending the previous Inspire study of the […]
Reprieve Cardio touts Reprieve-Guided diuretic therapy study data
Reprieve Cardiovascular last Saturday released results from two trials of its Reprieve-Guided diuretic therapy exploring its use in treating patients hospitalized with acute heart failure, touting that the system allows for safe decongestion. Results from the trials were presented at the Heart Failure 2019 Congress in Athens, Greece, the Milford, Mass.-based company said. Reprieve Cardiovascular said […]
Biotronik launches next-gen ICD, CRT-D trial
Biotronik said yesterday that it launched a study of its new implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems. The BIO|MASTER.Cor Family study will explore clinical safety and workflow benefits of its ICD and CRT-D systems, specifically focused on gains from the thinner and more rounded shape, the Berlin-based company said. Biotrink said that […]
Beta Bionics starts new trial for bionic pancreas
Boston-based Beta Bionics said this week that the first patients have begun home use of dasiglucagon in a clinical trial of the company’s iLet bionic pancreas system for people with Type 1 diabetes. The iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous glucose […]