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 […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. […]
ICON expands EMEA reach with MeDiNova Research acquisition
ICON (NSDQ:ICLR) said today that it has acquired a majority share in MeDiNova Research, a site network with research sites in key markets in Europe and Africa, and that it has the right to acquire the remaining shares in the company by the third quarter of 2020. The acquisition adds to Dublin, Ireland-based ICON’s patient recruitment capabilities […]
Boston Scientific study to compare Watchman FLX with anticoagulant drugs
Boston Scientific (NYSE:BSX) said yesterday that it’s launching a large clinical trial to compare the latest iteration of its Watchman heart implant with anticoagulant drugs in reducing the risk of stroke in atrial fibrillation patients. The 1,600-patient Option randomized trial is designed to compare first-line oral anticoagulants with left atrial appendage occlusion using Watchman FLX in […]
Neovasc surges on two-year Reducer results
Two-year data from a trial of the Reducer anti-angina device made by Neovasc (NSDQ:NVCN), published this week in the International Journal of Cardiology, bore out earlier safety and efficacy results but showed no effect on the progression of coronary artery disease. The study examined angina symptoms, quality of life and adverse events at two years, […]
J&J’s Auris touts Monarch robotic bronchoscopy feasibility study
Johnson & Johnson‘s (NYSE:JNJ) Auris Health touted this week interim results from an independent feasibility study designed to assess the company’s Monarch robotic bronchoscopy technology. The Monarch Platform was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopic procedures. The study was set up to test the safety and feasibility of performing […]
FDA OKs AngioDynamics trial for NanoKnife in prostate cancer
AngioDynamics (NSDQ:ANGO) today announced the FDA has approved its investigational device exemption application for its NanoKnife irreversible electroporation pilot study. The non-randomized pilot study will include six subjects at up to three sites and is designed to inform the design of a pivotal clinical study in the U.S. to help support the company’s bid for pre-market […]
Ocular Therapeutix OTX-TP trial misses primary endpoint
A Phase 3 clinical trial of the ORX-TP eye insert made by Ocular Therapeutix (NSDQ:OCUL) failed to meet the primary endpoint of significant superiority in the reduction of intraocular pressure. OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of travoprost to reduce intraocular pressure. The randomized, double-blind, placebo-controlled clinical trial took place across more […]
EuroPCR 2019: Medtronic touts three-year registry data for Symplicity RDN
Medtronic (NYSE:MDT) this week presented three-year data from a registry study of its Symplicity renal denervation device for treating high blood pressure. Results from the 2,600-patient trial, which has 2,300 patients past the three-year mark, showed that ablation of nerves lining the renal arteries lowered in-office blood pressure measurements by 16.5mm Hg and cut ambulatory blood […]
Pavmed touts FIH CarpX study launch in pursuit of FDA 510(k) resubmission
Pavmed (NSDQ:PAVM) said yesterday that it launched a first-in-human safety study of its CarpX device to support a planned FDA 510(k) resubmission. The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes […]
FDA: Survival rates still low for Impella RP patients outside narrow patient selection criteria
The FDA today updated data from a post-approval study of Abiomed‘s (NSDQ:ABMD) Impella RP heart pump system, reporting a new 30-day survival rate of 28.6% for patients post-explant, hospital discharge or the start of longer term therapy. A total of 12 of the 42 patients enrolled in the post-market trial of the Danvers, Mass.-based medtech […]
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