Mercator MedSystems said today that the 1st patient was enrolled in its Tango clinical trial. The trial is evaluating Mercator’s Bullfrog micro-infusion device for the adventitial delivery of temsirolimus below the knee in patients with critical limb ischemia. The Tango trial is the 4th ongoing clinical trial using the Bullfrog device in below the knee applications […]
Clinical Trials
Alnylam, The Medicines Co., detail Phase III trial for RNA-based heart drug
The Medicines Co. (NSDQ:MDCO) and Alnylam Pharmaceuticals (NSDQ:ALNY) said today that they’ve reached a deal with the FDA over a Phase III trial for the companies’ RNA-based cholesterol-lowering drug, inclisiran. If approved, it would be the 1st RNA-interference therapy on the market. The drug is a part of a new group of drugs called PCSK9 […]
Nemaura prepares 2nd-gen SugarBeat patch for trials
Nemaura Medical said today it completed development of its 2nd-gen SugarBeat wireless skin-patch continuous glucose monitoring system and aims to launch clinical trials of the device shortly. The UK-based company’s SugarBeat CGM is designed as a wearable sensor patch which transmits data via bluetooth to provide real time glucose readings on a standalone reader, smart watch […]
Spirox touts 1-year 1st-in-human study results of Latera nasal implant
Spirox today released 1-year data from the 1st-in-human study of its Latera absorbable nasal implant designed to support nasal cartilage and prevent nasal valve collapse, which can contribute to nasal obstruction. Results from the study were published in the April issue of the journal Facial Plastic Surgery. Data from the study indicated that patients treated […]
Ivantis launches 2nd IDE study of Hydrus microstent
Ivantis said today it won approval from the FDA to initiate a 2nd investigational device exemption trial of its Hydrus microstent, testing the device in patients with advanced glaucoma who are undergoing stand-alone glaucoma surgery without combined cataract surgery. The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with […]
Tela Bio launches post-clinical OviTex ventral hernia repair study
Tela Bio said today it initiated a post-market clinical study of its OviTex reinforced bioscaffold designed for soft tissue repair, enrolling the 1st patient at La Jolla, Calif.’s Scripps Clinic. The Ovitex reinforced bioscaffolds are designed for hernia repair or abdominal wall reconstructions, Tela Bio said. The scaffolds are designed with either permanent polymer or resorbable polymers, […]
Medtronic touts drug-coated balloon in peripheral artery disease patients
Medtronic (NYSE:MDT) touted data today for its In.Pact Admiral drug-coated balloon in 2 sub-analyses of peripheral artery disease patients in the company’s In.Pact Global Study. The data were presented at the 2017 Charing Cross Symposium in London. Researchers presented 1-year outcomes in patients with complex lesions, as well as outcomes in a subset of patients with […]
Si-Bone touts 6-year iFuse data
Si-Bone today released data from a 6-year study of its iFuse Implant, touting significant reduction in opioid use for pain control in patients treated with the device. Data from the study, which compared the iFuse implant to both conservative management and radiofrequency denervation for treating SI joint pain, was published in the journal Neurosurgery. The iFuse […]
Study: Sirtex’s microspheres improve quality of life, but don’t extend survival
Sirtex Medical (ASX:SRX) said today that it’s yttrium-90 resin microspheres did not extend survival significantly compared to Bayer’s sorafenib in a study of patients with hepatocellular carcinoma. Although the 459-patient trial did not meet its primary endpoint, the company reported that patients treated with its microspheres experienced less than half the number of severe, treatment-related […]
Study: Gamida Cell’s NiCord cell graft yields fewer infections, shorter hospital stays
Gamida Cell said today that its NiCord cell graft produces fewer infections, shorter hospital stays and shorter time to engraftment compared to standard umbilical cord blood transplantation. The company’s work was published in Biology of Blood and Marrow Transplantation. Get the full story at our sister site, Drug Delivery Business News.
7 medtech stories we missed this week: April 21, 2017
From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer […]