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Procedure: Gastroschisis Repair

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Total 16 results found since Jan 2013.

Medtronic touts study data for thoracic aortic stent
Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study. The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented at The Society of Thoracic Surgeons annual meeting in San Diego this week. It was the first five-year, industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR). BTAI is...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials News Well Research & Development Stent Grafts Medtronic Society of Thoracic Surgeons Source Type: news

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

Gore touts first use of Tag conformable thoracic stent graft in Australia
W.L. Gore & Associates said yesterday that it launched its Gore Tag conformable thoracic stent graft with active control in Australia, touting that the first procedures with the device have been performed in the region. The first implant procedures with the device were performed by Dr. Ian Spark of Adelaide, Australia’s Flinders Medical Centre, Gore said. “The Gore Tag conformable stent graft is a reliable and trusted device that I have used for TEVAR procedures with my patients for many years. The availability of the new Gore Active Control System is an exciting advancement because it significantly enhanc...
Source: Mass Device - July 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stent Grafts Vascular W.L. Gore & Associates 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

Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients. The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy. “With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news

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 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints in t...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 1, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device against Boston Scientific’s Watchman St. Jude Medical said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, whic...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Micro Interventional Devices wins FDA nod for Permaseal
Micro Interventional Devices said today it won FDA 510(k) clearance for its Permaseal transapical access and closure device. The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology. “The FDA market clearance of Permaseal is another tremendous achievement for MID. This exciting development comes fast on the heels of our recent European approval.  Sales in Europe are exceeding our early expectations.  With the US approval, coming earlier than expected, MID will be initiating ...
Source: Mass Device - July 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Micro Interventional Devices Source Type: news

Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers. Broomfield, Colo.-based Colibri is running a 1st-in-human trial of the transcatheter aortic valve replacement it’s developing, a pre-mounted, pre-crimped and pre-packaged device that’s designed to be shipped ready to use, according to its website. Colibri has said that patients enrolled in the study showed no observed stroke, no pacemaker implantations, virtually no paravalvular leak and a high retained average effective orifice ...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Colibri Heart Valve Source Type: news

Silk Road Medical raises $57 million
Silk Road Medical today said it reeled in a $57 million equity-and-debt round from a group of new and existing backers. Sunnyvale, Calif.-based Silk Road, which makes the Enroute transcarotid artery stent and neuroprotection system, said CRG led the debt round and participated in the equity portion, joined by prior investors Warburg Pincus and The Vertical Group. “The strength of this financing is a testament to the large opportunity we have to solve unmet clinical needs and lead the next endovascular revolution with TCAR,” CEO Erica Rogers said in prepared remarks. “Our proprietary advances in tempo...
Source: Mass Device - October 20, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Stents Vascular Silk Road Medical Inc. Stroke Source Type: news

Silk Road launches Enroute transcarotid stent
Silk Road Medical said today it launched its Enroute Transcarotid stent system in the U.S., and that the stent was used in its 1st commercial commercial case. The Enroute stent is indicated for use in patients at high surgical risk in conjunction with the company’s transcarotid Neuroprotection system, the Sunnyvale, Calif.-based company said. The stent is also the 1st designed to be implanted into the carotid artery through a common access point. “The minimally invasive TCAR procedure allows me to safely and quickly treat a carotid artery blockage while minimizing the potential for nerve injury and cardiovascul...
Source: Mass Device - October 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Silk Road Medical Inc. Source Type: news

HeartStitch touts new PFO closure method
Structural heart focused HeartStitch said today its NobleStitch EL device was used to repair 3 patients with patent forman ovale heart defects in Astana, Kazakhstan. A patent foramen ovale is a congenital heart disease in which hole in the heart that normally seals at birth remains open, and can lead to severe migraines, visual auras and stroke, the company said. The procedures were performed by Dr. Michael Mullen and guided by Anthony Nobles at the National Research Cardiac Surgery Center in Astana, according to the company. “We are gratified that our colleagues from abroad have brought this technology to Kazakhstan...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular HeartStitch Source Type: news

Boston Scientific lands another date with FDA panel for Watchman stroke device
An FDA advisory panel is slated to convene yet again in October to consider the safety and efficacy of Boston Scientific's Watchman anti-stroke heart repair device. Boston Scientific, Food & Drug Administration (FDA)News Well, Cardiac Implants, Pre-Market Approval (PMA), Regulatory/Complianceread more
Source: Mass Device - August 26, 2014 Category: Medical Equipment Authors: Brad Perriello Source Type: news

FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device
The FDA wants to convene another advisory panel on Boston Scientific's Watchman anti-stroke heart repair device, CFO Dan Brennan told investors today in Boston, saying the development pushes the approval timeline into 2015. Boston Scientific, Food & Drug Administration (FDA)News Well, Cardiac Implants, Regulatory/Compliance, Wall Street Beatread more
Source: Mass Device - June 17, 2014 Category: Medical Equipment Authors: Brad Perriello Source Type: news