SentreHeart yesterday touted the first-in-human procedures involving its Lariat left atrial appendage closure device to reduce the risk of stroke in patients with atrial fibrillation. The initial nine procedures, performed by Drs. Kryzstof Bartus and Randy Lee at Krakow, Poland’s John Paul II hospital, used the EpiRail vacuum stabilization system for an epicardial-only, percutaneous approach […]
Clinical Trials
Medpace jumps on Q2 beats
Medpace (NSDQ:MEDP) shares surged today after the contract research organization posted second-quarter numbers that topped the consensus forecast. Cincinnati-based Medpace reported profits of $27.5 million, or 73¢ per share, on sales of $214.1 million for the three months ended June 30, representing a bottom-line gain of 65.7% on sales growth of 25.8% compared with Q2 […]
Hancock Jaffe touts early results of VenoValve study
Hancock Jaffe Laboratories (NSDQ:HJLI) said today that reflux has been reduced to normal levels in four of the first patients to receive its VenoValve device, 90 days after implantation. The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg […]
Edwards Lifesciences abandons Centera self-expanding TAVR for Sapien 3 Ultra push
Edwards Lifesciences (NYSE:EW) is discontinuing work on its Centera TAVR system as it increases focus on expanding indications for its Sapien 3 Ultra valve. The news — which came yesterday with the company’s second-quarter earnings announcement — comes weeks after an urgent field safety notice in which the company warned customers that it had received reports […]
Nanowear to launch trial of heart failure-monitoring underwear
Nanowear said today that it has launched a heart failure management and alert diagnostic validation study of its medical-grade, cloth-based nanosensor technology. The SimpleSense undergarment has a closed-loop machine learning platform designed to capture and algorithmically score phonocardiography, impedance cardiography measuring stroke volume and cardiac output, and multi-channel ECG assessing heart rate and heart rate […]
Centinel Spine wins FDA nod for Prodisc implants trial
Centinel Spine said yesterday that it won an investigational device exemption from the FDA for a clinical trial of its Prodisc cervical disc implants. New York City-based Centinel acquired the Prodisc assets from Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes in December 2017 for an undisclosed amount. The FDA IDE covers a two-level study of the company […]
BrainsWay touts results of dTMS study for depression
BrainsWay (NSDQ:BWAY) said today that a study shows that deep transcranial magnetic stimulation (dTMS) plus standard medication was significantly more effective at reducing depression levels among major depressive disorder (MDD) patients than standard medication alone. Researchers at the Psychiatric Hospital Sveti Ivan in Croatia conducted the 228-patient randomized controlled study independent of industry support. The […]
Titan Medical on track for FDA, CE Mark bids this year
Titan Medical (TSX:TMD;OTC:TITFX) said today that it’s on track to submit approval bids this year for its Sport robot-assisted surgery device in the U.S. and Europe. The Toronto-based company said it completed all procedures under Good Laboratory Practices guidelines for acute and chronic animal and human cadaver studies, with slated to follow by the end of […]
Musk’s NeuraLink eyes 2020 human trials for brain implant
NeuraLink yesterday pulled back the curtain on the implant it hopes will wirelessly enable the human brain to control machines, reportedly including the robot-assisted implantation system it devised for its “neural lace” sensors, the sensors themselves and a chip designed to clean and amplify brain signals. The Elon Musk-backed company had previously only described its […]
Boston Scientific aims for personalized Parkinson’s therapy with Vercise DBS
Dr. Rafael Carbunaru and his team at Boston Scientific (NYSE:BSX) have spent the last twenty years building, among other things, the Vercise deep brain stimulation system in an attempt to deliver precise, personalized therapy for people with Parkinson’s disease. “It’s a labor of love,” the VP of R&D told MassDevice.com. Carbunaru estimated there are roughly 1.2 […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be assessed for […]