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
Aortica touts FDA clearance to use Medtronic ’ s Valiant Navion in AAA IDE study
Aortica said today that the FDA approved the use of Medtronic‘s (NYSE:MDT) Valiant Navion stent graft system alongside Aortica’s AortaFit in a physician sponsored IDE study.
The study, being run by principal investigator Dr. Benjamin Starnes at the University of Washington, will now use the Valiant Navion as a platform for fenestrated endovascular repair together with the AortaFit automated case planning software.
“I am excited to bring Medtronic’s Navion into this study. The device architecture incorporates many of the features we feel are important to simplifying fenestrated EVAR and addressing many ...
Source: Mass Device - December 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Vascular Aortica Medtronic Source Type: news
Medtronic touts 3-year Heli-FX EndoAnchor registry study data
Medtronic (NYSE:MDT) today released three-year data from the Anchor registry study of its Heli-FX EndoAnchor system, touting that it indicated the system is safe, efficient and durable in treating patients with complex aortic abdominal aneurysm anatomy, specifically those with hostile aortic neck anatomies.
Results from the trial were presented by co-principal investigator Dr. William Jordan of the Emory University School of Medicine at the 45th Annual Symposium of Vascular and Endovascular Issues in New York, the Fridley, Minn.-based company said.
“Hostile aortic necks are frequently seen in clinical practice and h...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Vascular Medtronic Source Type: news
FDA approves Medtronic ’ s Valiant Navion thoracic stent graft
Medtronic (NYSE:MDT) said today that it won FDA approval for its Valiant Navion thoracic stent graft system intended for use in the minimally invasive repair of lesions in the descending thoracic aorta.
The Fridley, Minn.-based company said that the stent system is now cleared for use in procedures to repair thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and aortic type B dissections.
Medtronic said that the newly cleared Valiant Navion stent will enable patients with small iliac arteries to undergo thoracic endovascular aneurysm repairs, and will open pe...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance Stent Grafts Stents Vascular Medtronic Source Type: news
FDA: Endologix recall of AFX stent graft is Class I
Endologix (NSDQ:ELGX) said late last week that the FDA classified its voluntary recall of AFX Endovascular abdominal aortic aneurysm stent graft systems as Class I.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Irvine, Calif.-based company said it issued its recall action in July, sending safety notices to healthcare professionals who use the system. The notice included updated information on comparative Type III endoleak rates associated with the device, as well ...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Recalls Regulatory/Compliance Vascular Endologix Source Type: news
Gore ’s aneurysm device for tricky anatomies implanted in Europe
(Image courtesy of W.L. Gore & Associates)
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates.
The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck angles of up to 90 degrees with a minimum 15 mm aortic neck length and patients with proximal aortic neck angles of up to 60 degrees with a 10 mm minimum aortic neck leng...
Source: Mass Device - September 17, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Implants Surgical W.L. Gore & Associates Source Type: news
Gore Wins 3 Nods for Molding and Occlusion Balloon
W.L. Gore & Associates has won approvals and clearances from a wide variety of regulatory bodies for its Molding and Occlusion Balloon. The technology has received FDA clearance; a CE mark; and approval from the Japanese Ministry of Health, Labour, and Welfare.
The Flagstaff, AZ-based company’s device is a compliant polyurethane balloon catheter. The Molding and Occlusion Balloon was designed in close collaboration with clinicians to assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels.
Gore said the new device meets all endovascular aortic repair (EV...
Source: MDDI - August 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
Gore touts regulatory wins for new balloon catheter
W.L. Gore & Assoc. said today that its molding & occlusion balloon won a trifecta of regulatory nods in the U.S., Japan and Europe.
The Flagstaff, Ariz.-based company said the device is designed to deliver stent grafts or temporarily occlude large-diameter vessels during endovascular aortic repair procedures. In addition to 510(k) clearance from the FDA, the balloon won CE Mark approval in the European Union and a nod from Japan’s Ministry of Health, Labor & Welfare.
It’s designed to be compatible both with Gore’s Excluder stent graft and any future such devices Gore puts on the market, the...
Source: Mass Device - August 23, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Regulatory/Compliance Stent Grafts W.L. Gore & Associates Source Type: news
Declining Sales Prompts Endologix to Hit the Strategic Reset Button
John Onopchenko has had his work cut out for him since being promoted to CEO of Endologix in May.
The company's revenue dropped 6.1% in the fiscal year 2017 compared to the fiscal year 2016 after a manufacturing glitch interrupted sales of its top-selling device for abdominal aortic aneurysms (AAA). This and other issues led CEO John McDermott to resign earlier this year.
"The leadership team and I have been working hard on reestablishing Endologix's credibility and reputation with our physicians and customers and building a culture of accountability, with the ultimate goal of delivering...
Source: MDDI - August 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
Cath Lab Recap: TAVR MEDCAC; ICA Calcified in Kids; Fenestrated EVAR
(MedPage Today) -- Interventional cardiology news to note (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - July 26, 2018 Category: Neurology Source Type: news
Out with the Old, in with the ... Newish?
It takes a strong leader to admit when his time is up. Endologix CEO John McDermott is that type of leader, which he proved this week with the announcement that he will be stepping down as CEO of the struggling endovascular aneurysm repair (EVAR) company.
Endologix has had its fair share of hurdles over the past couple of years, but it seems like things might finally be looking up for the Irvine, CA-based company.
In May, the company promoted John Onopchenko to the role of CEO. Prior to the promotion, Onopchenko was the company's chief operating officer, a position he took in October 2017.
"At that time, ...
Source: MDDI - July 16, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
MicroPort < sup > ® < /sup > NeuroTech Hosts Intracranial Vascular Endovascular Repair Summit
(Source: Microport News Release)
Source: Microport News Release - June 29, 2018 Category: Medical Devices Source Type: news
Endologix reports 1-year data from Ovation registry
Endologix (NSDQ:ELGX) this week touted 1-year results from its Lucy registry – a study that prospectively assessed endovascular aneurysm repair outcomes in women compared to men.
The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system compared to other EVAR systems.
The study enrolled 225 people, 76 women in the treatment group and 149 men in the control group, and the primary endpoint was the 30-day major adverse event rate. Secondary endpoints included serious and non-seri...
Source: Mass Device - June 28, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Vascular Women's Health Endologix Source Type: news
FDA panel backs Cardinal Health ’ s Incraft stent graft
Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system.
The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced endovascular aneurysm system for treating infrarenal abdominal aortic aneurysms, the Dublin, Ohio-based company said.
The Incraft AAA system differs from other EVAR systems as it is intended to treat a wider range of patients, as many EVAR devices are limited ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Stent Grafts Vascular Cardinal Health Source Type: news
Endologix promotes COO to corner office, posts mixed Q1 results
Endologix (NSDQ:ELGX) promoted chief operating officer John Onopchenko to CEO just in time for him to take the lead on the company’s first-quarter financial results.
Onopchenko served as the Irvine, Calif.-based company’s COO for the past seven months. He has spent 30 years in the medical device industry, including nearly a decade at Johnson & Johnson (NYSE:JNJ), where he led medical device investments and worldwide operations for the company’s advanced sterilization products unit.
“Since joining the company as COO, I have been deeply involved in the operations of the organization, and I’...
Source: Mass Device - May 4, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: MassDevice Earnings Roundup Stent Grafts Vascular Wall Street Beat Endologix johnsonandjohnson Source Type: news
