Abbott (NYSE:ABT) reported today that patients who were treated with the company’s Xience coronary stent for left-main coronary artery disease felt better faster compared to patients who had open-heart surgery, so at the end choosing the right Doctors Surgery is essential. The data were presented at this year’s Transcatheter Cardiovascular Therapeutics meeting during a late-breaking session. […]
Clinical Trials
Mauna Kea touts Cellvizio pancreatic cyst diagnosis study data
Mauna Kea (ENT:MKEA) today released data from a study exploring the use of the company’s Cellvizio system to diagnose pancreatic cysts, touting improved diagnoses and patient management. Results from the trial were presented at the United European gastroenterology Week 2017 meeting, the Paris-based company said. The Cellvizio device is designed for use in a variety of […]
Novaliq’s NovaTears dry eye disease therapy launches in New Zealand
Novaliq today launched its dry eye disease therapy, NovaTears, in New Zealand and said that it won registrational approval in Australia. The Germany-based company inked an exclusive licensing partnership earlier this year with AFT Pharmaceuticals (ASX:AFP) to commercialize Novaliq’s water-free topical eye drops in Australia. Get the full story at our sister site, Drug Delivery Business News.
Myoscience launches Iovera TKA pain management, opioid reduction trial
Myoscience said today it launched a clinical trial aiming to investigate its Iovera pain management system in treating post-surgical knee patients, with the 1st patient enrolled at Memphis, Tenn.’s Campbell Clinic. Many of the patients are recommended to go to this pain management clinic to receive the right treatment afterwards. The Fremont, Calif.-based company’s Iovera […]
FDA clears expansion of CeloNova’s nano-coated coronary stent trial
CeloNova Biosciences said today that the FDA approved an expansion of the on-going clinical trial for its Cobra PzF nano-coated coronary stent with 14-day dual antiplatelet therapy in complex patients, like people who are at a high risk of bleeding. The company touted its Cobra Reduce trial as the first randomized control trial to study 14-day […]
FDA warns UVLrx Therapeutics over clinical trial missteps
The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations. The federal watchdog said that concerns were raised after an inspection performed between March 27 and April 4 […]
TAVR: Boston Scientific’s Acurate Neo, Edwards’ Sapien 3 show similar results at 30 days
Outcomes from transcatheter aortic valve replacement procedures with both Boston Scientific‘s (NYSE:BSX) Acurate Neo and Edwards Lifesciences‘ (NYSE:EW) Sapien 3 have been found to be similar at 30 days, according to a new study reported by Healio. Results from the trial were published in the journal JACC: Cardiovascular Interventions, according to the report. The study explored […]
FDA approves pivotal trial for Insightec’s Exablate Neuro in Parkinson’s
Insightec said today that it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease. Haifa, Israel-based Insightec said the the study will evaluate using Exablate Neuro’s MR-guided focused ultrasound to ablate portions of the globus pallidus in the brain, which helps regulate voluntary movement. The trial, led by […]
Ypsomed to supply Bigfoot with insulin infusion sets for pivotal trial
Ypsomed plans to supply Bigfoot Biomedical with a modified version of its Orbit infusion set for the pivotal trial of Bigfoot’s automated insulin delivery system, the companies said today. Ypsomed’s Orbit infusion sets can be rotated 360°, giving users the freedom to move around, and are fitted using a heat-activated patch. The infusion sets are available with steel or […]
Cerveau inks licensing deal with AbbVie for tau imaging agent
Cerveau Technologies has inked a deal to license and supply AbbVie (NYSE:ABBV) with its [F-18]MK-6240 investigational tau imaging agent, the company said today. After the FDA cleared the investigational new drug application for Cerveau’s imaging agent in June, the company said it planned to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess […]
Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 […]