EVAR

Endologix Receives FDA Approval of PMA Supplement for AFX2 System

Retrieved on: 
Wednesday, December 7, 2022
Medical Devices, FDA, Health, Health Technology, Cardiology, Biotechnology, AAA, AFX, Food, EVAR, Medical journal, Sale, Randomized controlled trial, The BMJ, FDA, Vascular disease, Stent, Multimedia, PMA, Use, Food and Drug Administration, Mortality, Rupture, Aortic aneurysm, Acquisition, Pharmaceutical industry

Endologix LLC, a privately held global medical device company, dedicated to improving patients lives with innovative interventional treatments for vascular disease, today announced that it has received U.S. Food and Drug Administration (FDA) approval for a pre-market approval (PMA) supplement relating to the AFX2 System.

Key Points: 
  • Endologix LLC, a privately held global medical device company, dedicated to improving patients lives with innovative interventional treatments for vascular disease, today announced that it has received U.S. Food and Drug Administration (FDA) approval for a pre-market approval (PMA) supplement relating to the AFX2 System.
  • View the full release here: https://www.businesswire.com/news/home/20221207005348/en/
    Endologix received approval to include an updated warning and the most contemporary clinical information in the labeling for the AFX2 System.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.
  • The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body.

Preliminary Data from AAA-SHAPE to be Presented at VEITH 2022

Retrieved on: 
Monday, November 14, 2022
Medical Devices, Health, Surgery, Clinical Trials, Research, Science, Blood, EVAR, Completeness, Thought, Auckland City Hospital, CE, PMDA, Doctor of Philosophy, AAA, Bachelor of Medicine, Bachelor of Surgery, Aneurysm, MD, Abdominal aortic aneurysm, Patient, Medical imaging, EU

Data will be presented during the 49th Annual VEITH Symposium in New York City on Tuesday, November 15, 2022.

Key Points: 
  • Data will be presented during the 49th Annual VEITH Symposium in New York City on Tuesday, November 15, 2022.
  • The data will be presented by Professor Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and principal investigator for AAA-SHAPE Netherlands.
  • Active sac management may become an important addition to EVAR to improve the rate of sac shrinkage, said Reijnen.
  • Adjunctive aneurysm sac filling with shape memory polymer at the time of EVAR has the potential to improve sac regression.

Endologix Announces 12-Month Results of DETOUR-2 Trial at 2022 VIVA Late-Breaking Clinical Trial Session

Retrieved on: 
Friday, November 11, 2022
Health, Clinical Trials, Medical Devices, Amputation, CEO, Clinical trial, Sale, FDA, PBRC, Arnold, Cleveland, Calcification, DVT, Stent, Technology, EVAR, Death, PMA, MAE, Stenosis, PTAB, Advanced cardiac life support, Acquisition, IDE, Patient, Freedom, Quality of life, FACC, Safety, Forward-looking statement, Aortic aneurysm, VIVA, Conference, Vascular disease, Population, Department, Pulmonary embolism, First Ever, Medical imaging, Medical device, Health insurance, Pharmaceutical industry

The DETOUR 2 clinical trial has enrolled 202 patients in the United States and Europe for the primary analyses.

Key Points: 
  • The DETOUR 2 clinical trial has enrolled 202 patients in the United States and Europe for the primary analyses.
  • A Pre-Market Approval (PMA) Application for the DETOUR Systems was submitted to the FDA in October 2022.
  • The results presented are listed below:
    Ninety-six percent of enrolled patients had chronic total occlusions, with a mean lesion length of 32.7cm.
  • The 1-year effectiveness endpoint was also met, with 72.1% freedom from CD-TLR and recurrent stenosis > 50% at 12 months.

Saranas Announces Over 1,200 Patients Treated with the Early Bird® Bleed Monitoring System

Retrieved on: 
Wednesday, November 9, 2022
Surgery, Health, Medical Devices, CT, ST, Morristown Medical Center, Aortic valve, Femoral artery, MCS, Food, JAMA Cardiology, Adoption, FIH, Detection, Structural heart disease, Classification, Bleeding, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, Early Bird, Cardiology, Early, Length of stay, Patient, Physician, De novo, EVAR, The Early Bird, TAVR, FDA, Trial of the century, Medical imaging, Birth control

Saranas, Inc. announced today that over 1,200 patients have been treated with the Early Bird Bleed Monitoring System, the first and only FDA-approved bleed detection system.

Key Points: 
  • Saranas, Inc. announced today that over 1,200 patients have been treated with the Early Bird Bleed Monitoring System, the first and only FDA-approved bleed detection system.
  • The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.
  • The Early Bird Bleed Monitoring System includes a bleed detection array with integrated electrodes in a fully functional vascular access sheath.
  • First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events.

Endologix Reports Five-Year Data of the LEOPARD Trial at 2022 Vascular InterVentional Advances (VIVA) Conference

Retrieved on: 
Thursday, November 3, 2022
Health, Clinical Trials, Medical Devices, Freedom, Randomized controlled trial, Mortality, AFX, EVAR, Rupture, Sale, RCT, Industry, Vascular disease, Conference, Use-centered design, CEO, Patient safety, Aortic aneurysm, Medicine, Stent, Acquisition, ARC, Society, Patient, Medical imaging, Pharmaceutical industry, MD

Endologix LLC , a privately held global medical device company dedicated to improving patients lives by providing disruptive therapies for the interventional treatment of vascular disease, announced the five-year results from the LEOPARD randomized controlled trial.

Key Points: 
  • Endologix LLC , a privately held global medical device company dedicated to improving patients lives by providing disruptive therapies for the interventional treatment of vascular disease, announced the five-year results from the LEOPARD randomized controlled trial.
  • LEOPARD was a prospective multi-center trial designed to directly compare the anatomically fixated AFX2 Endovascular AAA System and the predecessor AFX device, to commercially available endografts with proximal fixation.
  • The LEOPARD trial enrolled 455 patients across 56 US Centers.
  • These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease.

Endovascular Aneurysm Repair Global Market Report 2022: Advantages Over Open Heart Surgery Driving Adoption & Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, October 20, 2022
Surgery, Health, Other Health, Terumo, Atherosclerosis, Physician, Pulmonary embolism, Anatomy, Growth, CAGR, Degenerative disease, EVAR, Porter's five forces analysis, Research, Medtronic, Aorta, Awareness, Site, AAA, Aortic aneurysm, FDA, Abdominal aortic aneurysm, Benchmarking, Aortic rupture, Pharmaceutical industry, Ridesharing company

Endovascular aneurysm repair (EVAR) is a preferred treatment option for aortic aneurysm, owing to its advantages over open surgery.

Key Points: 
  • Endovascular aneurysm repair (EVAR) is a preferred treatment option for aortic aneurysm, owing to its advantages over open surgery.
  • The endovascular aneurysm repair industry report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the endovascular aneurysm repair market analysis from 2020 to 2030 to identify the prevailing endovascular aneurysm repair market opportunities.
  • In-depth analysis of the endovascular aneurysm repair market segmentation assists to determine the prevailing market opportunities.
  • The report includes the analysis of the regional as well as global endovascular aneurysm repair market trends, key players, market segments, application areas, and market growth strategies.

ELEVATE IDE Study highlights the Safety and Effectiveness of the ALTO® Abdominal Stent Graft System in One-year Results; Data to Be Presented at 2022 VEITHsymposium

Retrieved on: 
Thursday, October 20, 2022
Health, Surgery, Clinical Trials, Medical Devices, Sale, Technology, Anatomy, Patient, EVAR, Society for Vascular Surgery, ISSN, Multimedia, Mortality, CT, Vascular disease, MD, Department, Acquisition, JAGUAR, Renal artery, AAAS, CEO, Cleveland Clinic, ALTO, Journal, Randomized controlled trial, AAA, Forward-looking statement, Aortic aneurysm, Stent, FDA, IDE, Medical imaging, Pharmaceutical industry

The study reports the clinical outcomes of the ALTO Abdominal Stent Graft System and highlights the devices safety and effectiveness at one-year post-procedure.

Key Points: 
  • The study reports the clinical outcomes of the ALTO Abdominal Stent Graft System and highlights the devices safety and effectiveness at one-year post-procedure.
  • The study concluded that the Endologix ALTO stent graft is safe and effective in treating AAA with appropriate anatomy at one year.
  • Featuring a unique, patented, sealing technology, the ALTO Abdominal Stent Graft System is the latest generation of innovative therapies for AAA patients.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.

 Endologix Submits Premarket Approval (PMA) Application to FDA for the DETOURTM System.

Retrieved on: 
Monday, October 10, 2022
Health, FDA, Medical Devices, Surgery, Clinical Trials, Cardiology, Biotechnology, Physician, Sale, Femoral vein, PMA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, EVAR, Moyamoya disease, Food, Vascular disease, Acquisition, MD, Society, Disease, CEO, Aortic aneurysm, Stent, Failure, FDA, IDE, Pharmaceutical industry, SFA

The PMA application includes the results of the DETOUR2 IDE study, which were presented at the 2022 Annual Meeting of the Society for Vascular Surgery this past June.

Key Points: 
  • The PMA application includes the results of the DETOUR2 IDE study, which were presented at the 2022 Annual Meeting of the Society for Vascular Surgery this past June.
  • The trial demonstrated technical success of 100% in 202 patients with a 30-day Major Adverse Event Rate of 7%.
  • This submission is a significant milestone in our mission to expand our therapeutic products into the large peripheral vascular market opportunity.
  • Endologix LLC is a California-based, global medical device company dedicated to improving patients lives by providing innovative therapies for the interventional treatment of vascular disease.

Shape Memory Medical Completes Enrollment in the AAA-SHAPE Early Feasibility Study

Retrieved on: 
Monday, August 29, 2022
Health, Medical Devices, Surgery, Clinical Trials, Research, Science, Cardiology, Patient, Doctor of Philosophy, EVAR, AAA, Blood, Abdominal aortic aneurysm, Bachelor of Medicine, Bachelor of Surgery, MD, Auckland City Hospital, PMDA, CE, Aneurysm, Trial of the century, Pharmaceutical industry, Transformer, Medical imaging, EU

Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral and neurovascular markets, announced the completion of patient enrollment in AAA-SHAPE, the Companys prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

Key Points: 
  • Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral and neurovascular markets, announced the completion of patient enrollment in AAA-SHAPE, the Companys prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
  • We are pleased to reach this critical milestone in our AAA-SHAPE clinical program, said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical.
  • IMPEDE-FX RapidFill, the study device, incorporates a proprietary shape memory polymer, which is a high volume, porous embolic material that self-expands upon contact with blood.
  • Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers.

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

Retrieved on: 
Thursday, August 4, 2022
Health, Medical Devices, Cardiology, MDD, Freedom, Union, Vascular disease, Patient, PAD, AFX, AAA, Quality, Safety, European Commission, Moyamoya disease, Medical Devices Directive, Randomized controlled trial, Technology, Aortic aneurysm, Aneurysm, Forward-looking statement, CEO, Certification, EVAR, Royal commission, Medical device, Acquisition, MDR, EU

Endologix LLC , a privately held global medical device company dedicated to improving patients lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.

Key Points: 
  • Endologix LLC , a privately held global medical device company dedicated to improving patients lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.
  • CE Mark certification under the new requirements is a high-bar and we are proud of this significant company achievement.
  • Meeting the rigor of the new framework is an important milestone for our AFX2 System, said Elisa Hebb, Endologixs EVP of Medical, Clinical, Regulatory Affairs and Quality.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.