Medtronic launches Endurant II, IIs ChEVAR real-world study
Medtronic (NYSE:MDT) said today it launched a study of its Endurant II and IIs stent graft systems, designed to treat abdominal aortic aneurysms, exploring the use of the device in ChEVAR procedures in real-world settings.
The 150-patient, single-arm study is slated to enroll patients at 25 sites across Europe and Russia, with the first enrollments already underway at Munster, Germany’s St. Franziskus Hospital led by principal investigator Dr. Giovanni Torsello.
“We are excited to initiate this study in a real-world population, which will build upon existing clinical evidence for the ChEVAR technique as a stan...
Source: Mass Device - January 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Medtronic Source Type: news
Gore launches FDA IDE Excluder conformable AAA endoprosthesis trial
W.L. Gore & Associates today announced the first implant of its Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the US as part of an FDA-approved investigational clinical study.
The procedure was performed on December 19 at New York’s Maimonides Medical Center by national principal investigator Dr. Robert Rhee.
“Patients with extreme proximal neck anatomies often do not qualify for EVAR. Regardless of device flexibility, current delivery systems make it difficult to achieve conformability during deployment. The angulation control in the new delivery system for the Gore Excluder Confor...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular W.L. Gore & Associates Source Type: news
Endovascular Repair of Abdominal Aortic Aneurysm Endovascular Repair of Abdominal Aortic Aneurysm
How might endovascular aneurysm repair benefit patients with abdominal aortic aneurysm who are physically frail and ineligible for open repair?Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 15, 2017 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news
Endovascular Versus Open Repair of Abdominal Aortic Aneurysms Endovascular Versus Open Repair of Abdominal Aortic Aneurysms
Dr Lowenfels comments on a report, published in Surgery, that compares the two procedures for AAA. What have we learned to date?Medscape General Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 14, 2017 Category: Consumer Health News Tags: General Surgery Viewpoint Source Type: news
Endovascular Repair of Ruptured AAA Improves Midterm Survival Endovascular Repair of Ruptured AAA Improves Midterm Survival
Endovascular repair of ruptured abdominal aortic aneurysm was linked to reduced mortality at 3 years, improved early quality of life, and reduced costs compared with open surgery in the IMPROVE trial.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 20, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news
Metformin and Growth Rate of Abdominal Aortic Aneurysms Metformin and Growth Rate of Abdominal Aortic Aneurysms
Dr Lowenfels comments on a study that investigated whether metformin could significantly slow the growth rate of this very common disease.Medscape General Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 16, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery Viewpoint Source Type: news
Abdominal Aortic Aneurysm (Symptoms, Repair, Surgery, Survival Rate)
Title: Abdominal Aortic Aneurysm (Symptoms, Repair, Surgery, Survival Rate)Category: Diseases and ConditionsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 11/15/2017 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - November 15, 2017 Category: Cardiology Source Type: news
Abdominal aortic aneurysm linked to dysregulated tryptophan metabolism, study finds
(Georgia State University) Researchers have found a link between dysregulated tryptophan metabolism and abdominal aortic aneurysm, a life-threatening vascular disease, according to a new study led by Georgia State University. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 13, 2017 Category: International Medicine & Public Health 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
This Device Has Been Around for 20 Years
It comes in different sizes and configurations now, but the Gore Excluder AAA Endoprosthesis, which seals off abdominal aneurysms from inside the aorta, hasn’t changed radically since it was introduced to the European market in 1997.
The endovascular aneurysm repair (EVAR) device has been implanted in more than 300,000 patients diagnosed with an abdominal aortic aneurysm (AAA), according to its manufacturer, W.L. Gore & Associates. Before EVAR, patients with AAA had two options: major surgery to repair the aneurysm or crossed fingers.
“The number of patients who were not candidates for surgery really drove the earl...
Source: MDDI - October 13, 2017 Category: Medical Devices Authors: Nancy Crotti Tags: Implants Design Source Type: news
Medtronic breaks ground on western China Innovation Center
Medtronic (NYSE:MDT) said today it has begun work on an Innovation Center in Chengdu, China, slated to open in 2020.
The new Chengdu Innovation Center is being built at the Singapore-Sichuan Hi-Tech Innovation Park in the Sichuan Province and aims to provide clinical training and research platforms for medical workers in the region and neighboring regions.
“Medtronic understands the critical role that rural physicians play in driving the healthcare availability and transformation. As such, we hope to support the growth and development of medical workers in China’s vast central and western regions, help them be...
Source: Mass Device - October 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Medtronic Source Type: news
Medtronic wins expanded FDA nod for Endurant II stent graft
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies.
Prior to receiving the clearance, patients with short infra-renal necks were classified as ineligible for endovascular aneurysm repair, the Fridley, Minn.-based company said. Medtronic estimates that 10-13% of AAA patients have AAA proximal neck anatomies of lower than or equal to 10mm.
“Due to the complex and hostile proximal aortic...
Source: Mass Device - October 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Stents Vascular Medtronic Source Type: news
Endologix wins refined CE Mark indications for Nellix stent graft
Endologix (NSDQ:ELGX) said today it won expanded CE Mark approval in the European Union for its Nellix endovascular aneurysm sealing system with refined indications for use.
The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical performance requirements.
“We are very pleased with the clinical outcomes generated by the Nellix EndoVascular Aneurysm Sealing System utilizing the refined IFU. The Nellix CE Mark with the refined IFU provides patients and physicians in Europe with...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Stent Grafts Vascular Endologix Source Type: news
Lombard touts expected 50% cost reduction in restructuring effort
Lombard Medical Technologies (NSDQ:EVAR) said today it completed a restructuring of its business after implementing a plan to focus its sales efforts on the UK, Japan and China, as well as reducing operating and manufacturing costs as it seeks to breakeven with its cash flow.
The UK-based company said that the restructuring is expected to result in a reudction of nearly $12 million in operating expenses next year when compared to last years expenditure levels, with costs reduced more than 50%.
“During 2017, we have refocused sales and marketing activities in an effort to concentrate on our highest margin markets. We...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News lombardmedical MicroPort Scientific Source Type: news
