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Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentinel d...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity
We presented positive initial results in Crohn’s disease at the 2016 United European Gastroenterology meeting: six of the eight patients had seen a substantial reduction in their disease activity index scores, and three were in remission from the disease. As SetPoint looks ahead, several chronic disease areas are emerging as key bioelectronic medicine therapy targets, and our company is exploring a number of these. One of our preclinical programs explores bioelectronic medicine’s potential role as a treatment for MS.   New Target: Multiple Sclerosis In late 2017, SetPoint presented positive data from a study exp...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Anthony Arnold Tags: Bioelectronic Medicine Clinical Trials Neuromodulation/Neurostimulation SetPoint Medical Sponsored Content Source Type: news

FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device
Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed to compare treatment with MobiusHD and a sham procedure. The primary safety endpoint is a composite of death, myocardial infarction, stroke, device embolization, carotid occlusion, new ipsilateral carotid stenosis requiring surgic...
Source: Mass Device - August 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance vasculardynamics Source Type: news

Organovo CEO Murphy steps away, Crouch steps up | Personnel Moves – April 14, 2017
Organovo (PINK:ONVO) said earlier this week that Taylor Crouch has been appointed as CEO, replacing Keith Murphy who is stepping away from the company. The changes are slated to go into effect on April 21. Prior to being tapped for  the corner office, Crouch operated as CEO of investigative clinical research company eStudySite, the San Diego, Calif.-based company said. “I am extremely proud of the progress we have made in the last ten years achieving our vision for Organovo.  Our 3D bioprinted human tissues are a disruptive and game-changing technology.  Founding Organovo and guiding us to our leadership position...
Source: Mass Device - April 14, 2017 Category: Medical Equipment Authors: MassDevice staff Tags: Business/Financial News Active Implants AdvaMed Alphatec Holdings Inc. Anika Therapeutics Inc. Apollo Endosurgery Aurora Spine Baxter Biocorp Biogen Idec Biolase Technology Inc Bioventus LLC Bonesupport Clal Biotech Delcath Sys Source Type: news

Nico launches trial for brain surgery shunt
Nico Corp said today it enrolled the 1st patient in the Enrich clinical trial which aims to explore the use of its BrainPath Approach for treating intracerebral hemorrhages. The trial will examine the procedural safety as well as economic and functional benefit of early surgical removal of intracerebral hemorrhages using its BrainPath Approach system. “Our initial clinical results with this approach for early clot removal have been exciting and provided a wake-up call to what has been missing in hemorrhagic stroke care,” trial principal investigator Dr. Daniel Barrow said in a press release. Indianapolis, I...
Source: Mass Device - January 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Nico Corp. Source Type: news

TAVI: Boston Scientific’s Lotus valve tops Medtronic’s CoreValve – study
Data from a study of Boston Scientific‘s (NYSE:BSX) Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients. The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve device. Success rates were higher at 30 days in the Lotus group, at 84%, versus 64% with CoreValve, according to the study.  These results...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific JACC: Cardiovascular Interventions medtronic Source Type: news