Endovascular Abdominal Aortic Aneurysm Repair Outcomes Worse for Women
WEDNESDAY, July 27, 2022 -- Female sex is associated with decreased five-year survival and increased one- and five-year reintervention after elective endovascular abdominal aortic aneurysm repair (EVAR), according to a study published online June 12... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 27, 2022 Category: Pharmaceuticals Source Type: news

FDA Urges Lifelong Follow-Up After Endovascular Aortic Repair FDA Urges Lifelong Follow-Up After Endovascular Aortic Repair
Regular imaging surveillance, within 30 days of EVAR and annually thereafter, can help identify adverse events after abdominal aortic aneurysm, the FDA says in a letter to healthcare professionals.News Alerts (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - March 1, 2022 Category: Intensive Care Tags: Cardiology News Alert Source Type: news

Higher Long-term Mortality Seen With Endovascular Aortic Aneurysm Repair Higher Long-term Mortality Seen With Endovascular Aortic Aneurysm Repair
Patients undergoing endovascular repair of an intact abdominal aortic aneurysm have a lower risk of death in the short term than do those undergoing open surgery, according to new findings.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - November 24, 2021 Category: Surgery Tags: Cardiology News Source Type: news

Dutch MedTech STENTiT appoints Golo von Basum as Chief Operating Officer
EINDHOVEN, Netherlands, June 15, 2021 -- (Healthcare Sales & Marketing Network) -- STENTiT, a medical device company bringing a novel class of regenerative stents for sustained endovascular repair, has appointed Dr. Golo von Basum (picture) as its Chief O... Devices, Regenerative Medicine, Personnel STENTiT , regenerative stent, regenerative endovascular implant (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 15, 2021 Category: Pharmaceuticals Source Type: news

Endovascular aneurysm repair linked to higher readmission rates
(University of Missouri-Columbia) Ruptured abdominal aortic aneurysms (rAAA) are responsible for nearly 2% of all deaths in U.S. men over the age of 65. Endovascular aneurysm repair (EVAR) has emerged as a newer and less invasive alternative to open repair for rAAA. But researchers from the University of Missouri School of Medicine have discovered that while EVAR is more commonly utilized for rAA, the odds of hospital readmission after EVAR are 1.5 times higher compared to traditional open repair. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 10, 2021 Category: International Medicine & Public Health Source Type: news

Endologix Takes a Step Forward with Nellix IDE
Endologix has received investigational device exemption (IDE) approval from FDA for a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney Endovascular Aneurysm Sealing System for the endovascular treatment of complex abdominal aortic aneurysms (AAA). The system is an endovascular abdominal aortic aneurysm therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxta-renal, para-renal, and suprarenal AAA. The application of endovascular aneurysm sealing for patients with complex aneurysms will offer innovativ...
Source: MDDI - August 9, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Regulatory and Compliance Source Type: news

Long-Term Survival Similar for Endovascular, Open AAA Repair
WEDNESDAY, May 29, 2019 -- For patients with asymptomatic abdominal aortic aneurysm, long-term overall survival is similar with either endovascular repair or open repair, according to a study published in the May 30 issue of the New England Journal... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 29, 2019 Category: Pharmaceuticals Source Type: news

Gore Scores FDA Nod for More Precise TEVAR Solution
W.L. Gore and Associates has received a nod from FDA for a more precise Thoracic Endovascular Aortic Repair (TEVAR) solution. The Flagstaff, AZ-based company said the Gore Tag Conformable Thoracic Stent Graft with Active Control System provides new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B dissections of the descending thoracic aorta. A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes. “Gore has been on the front end and has really defined and established the TEVAR minimally invasi...
Source: MDDI - May 21, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

How Endologix Renewed One Doctor & #039;s Confidence in the Ovation Device
It's been a turbulent couple of years for Endologix, but as MD+DI reported in February, the company has been working hard to win back customers. During the company's first-quarter earnings call, CEO John Onopchenko shared a story about a physician at an academic medical center in the Western United States (he did not disclose the name of the physician or the center) who had used Ovation only twice over the course of 2017 and 2018.  Irvine, CA-based Endologix acquired the Ovation platform through its merger with TriVascular in February 2016. It's a low-profile device that has broadened the company's portfolio in...
Source: MDDI - May 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

FDA approves Intact Vascular ’ s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news

Superior Survival With TEVAR vs Open Aortic Aneurysm Repair Superior Survival With TEVAR vs Open Aortic Aneurysm Repair
Endovascular repair is increasingly used instead of open surgery for descending thoracic aortic aneurysms. Now, a new study suggests that TEVAR should be the standard of care.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 21, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news

Affluent Medical touts results of endovascular aneurysm repair study
Medtech startup Affluent Medical (Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter. The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure to prevent endoleaks and the recurrence of the condition. The Scope 1 randomized, controlled, multicentric clinical trial enrolled 102 patients at four sites in France, beginning in 2013. With a 24-month follow-up ...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Clinical Trials Featured News Well Research & Development affluentmedical Source Type: news

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