Endologix (NSDQ:ELGX) today announced the presentation of 2-year data from the EVAS Forward IDE trial of its Nellix stent graft for repairing abdominal aortic aneurysms, touting a high rate of freedom from endoleaks, ruptures and mortalities. Results from the trial were presented by study principal investigator Dr. Jeffrey Carpenter of New Jersey’s Cooper Medical Schoo and […]
Clinical Trials
SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage. Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA […]
Sirtex SIR-spheres fail to meet primary endpoint in head-to-head trial
Sirtex Medical (ASX:SRX) shares are down slightly today after its radioactive microspheres failed to meet the primary endpoint in a liver cancer trial. The company’s SIR-Spheres Y-90 resin microspheres did not improve survival in patients with advanced hepatocellular carcinoma compared to a group treated with the current standard of care, sorafenib. Get the full story at […]
AntriaBio seeks FDA nod for trial of once-weekly insulin
AntriaBio (OTC:ANTB) said today that it filed an investigational new drug application with the FDA for its once-weekly basal insulin. If the Louisville, Colo.-based company wins approval from the FDA, it plans to launch a Phase I clinical trial of AB101 in patients with Type I diabetes. Get the full story at our sister site, […]
7 medtech stories we missed this week: June 2, 2017
From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Dextera seeks expanded indications for MicroCutter 5/80 stapler Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The […]
Cingulate moves controlled-release ADHD drug to human testing
Cingulate Therapeutics said this week that it began a proof-of-concept trial for its controlled-release attention deficit/hyperactivity disorder drug. The 4-week clinical trial is being conducted by its development partner, Bio-Images Drug Delivery. The trial enrolled healthy volunteers to evaluate the pharmacokinetic behavior of CTX-1301, including the body’s absorption, distribution, metabolism and excretion of the drug. […]
BioCorRx partners with virtual reality center for naltrexone implant study
BioCorRx (OTC:BICX) said today that it partnered with the Virtual Reality Medical Center to conduct a study on the company’s long-lasting naltrexone implant. BioCorRx’s recovery program consists of a long-lasting implant that delivers an opioid antagonist, naltrexone, which reduces physical cravings for alcohol and opioids. The recovery service also has a counseling program specifically designed […]
Philips, Illumina to launch precision medicine cancer program with Navican
Royal Philips (NYSE:PHG) and Intermountain Healthcare company Navican inked an agreement today to launch a precision health informatics solution aimed at improving outcomes for late stage cancer patients. The program is slated to leverage Navican‘s TheraMap Precision Cancer Care services and Philips’ IntelliSpace Genomics platform, which uses Illumina‘s next-gen genomic sequencing technologies. At Utah-based Intermountain Healthcare’s […]
Endologix touts 30-day data from study of Ovation stent graft in women
Endologix (NSDQ:ELGX) touted 30-day data today from a trial evaluating its Ovation abdominal stent graft system in women. The Lucy trial showed that at least 28% more women became eligible for minimally-invasive endovascular aneurysm repair when using the Ovation stent graft. The study is the 1st to assess endovascular aneurysm repair outcomes in women, according to […]
Avinger touts 2-year Pantheris study data
Avinger today released data from the pivotal vision study of its Pantheris system, touting high survivability and freedom from target lesion revascularization in patients treated with the system. The 89-patient Vision study aimed to evaluate the safety and effectiveness of its Pantheris directional atherectomy system which uses real-time intravascular imaging to remove plaque from diseased […]
Chiltern acquires Integrated Development Associates
Contract research organization Chiltern announced today that it is expanding its Japanese and Asian presence through its purchase of Integrated Development Associates. Financial terms of the deal were not disclosed. IDA has staff in Japan, Korea and Southeast Asia – and offers opportunities to integrate the region into global drug development, according to Chiltern. IDA’s expertise includes […]