After Many Missteps, Endologix Makes Progress on Nellix
Endologix just took a big step forward on what has been a long and winding road to FDA approval of its Nellix endovascular aneurysm sealing (EVAS) system. The Irvine, CA-based company said the first patient was treated in its EVAS2 confirmatory clinical study of the device.
The Nellix System was developed as an alternative treatment to traditional endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA). The system is designed to seal an entire aneurysm.
Endologix originally planned to have FDA approval of the Nellix system by the end of 2016, but the company hit a speed bump about midway through that yea...
Source: MDDI - March 5, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Medical Device Business Regulatory and Compliance Source Type: news
Endologix launches study of second-gen Nellix endovascular aneurysm sealing system
Endologix (NSDQ:ELGX) said today that the first patient was treated in a study of its Nellix endovascular aneurysm sealing system.
The company’s Nellix system, designed to seal a patient’s entire aneurysm, is being developed as an alternative to traditional EVAR devices. Endologix’s system has CE Mark clearance in the European Union and is sold in a number of markets around the world.
The first patient in the company’s confirmatory IDE study was treated by Dr. Sajjad Hussain at St. Vincent Heart Center in Indiana. The EVAS2 trial is slated to enroll up to 90 patients and follow their progress over ...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Stent Grafts Vascular Wall Street Beat Endologix Source Type: news
Study compares countries' mortality rates after aneurysm surgery
(Wiley) There is substantial international variation in mortality rates after treatment for abdominal aortic aneurysm, or enlargement of the aorta. A BJS (British Journal of Surgery) study that compared 10-year data from England and Sweden found that mortality rates were initially better in Sweden but improved over time alongside greater use of a minimally invasive procedure called endovascular aneurysm repair in England. Now there is no difference between postoperative mortality rates after aneurysm repair in England and Sweden. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 22, 2018 Category: International Medicine & Public Health Source Type: news
Medtronic launches Abre stent iliofemoral venous outflow obstruction IDE study
Medtronic (NYSE:MDT) said today it launched an FDA investigational device exemption study of its Abre venous self-expanding stent system, looking to explore the use of the device in subjects with iliofemoral venous outflow obstruction.
The first procedure in the study was performed last month by national principal investigator Dr. Erin Murphy of Charlotte, N.C.’s Sanger Heart & Vascular Institute, the Fridley, Minn.-based company said.
“The launch of the Abre IDE Study marks the beginning of an important journey to establish new options for the treatment of deep venous disease. The first procedure was per...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Stents Vascular Medtronic Source Type: news
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
