EVAR

Saranas Reveals Groundbreaking SAFE-MCS Study Results at CRT 2024

Retrieved on: 
Monday, March 11, 2024
Surgery, Medical Devices, Health, Clinical Trials, Cardiology, CRT, Aortic stenosis, Physician, Risk, Early, Patient, Percutaneous coronary intervention, Henry Ford Health, MCS, PROTECT, Morristown Medical Center, Henry Ford, PCI, Bleeding, EVAR, Safety, Structural heart disease, TAVR, FDA

“This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.

Key Points: 
  • “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.
  • “We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Mike MacKinnon, CEO and President of Saranas.
  • Saranas is dedicated to establishing a new benchmark for bleed detection during and after endovascular procedures, with the goal of improving patient outcomes and decreasing healthcare expenses overall.”

Endologix Appoints Mike Mathias as Chief Commercial Officer

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, General Health, Medical Devices, Health, Pharmaceutical, TAVR, MD, Strategic planning, MBA, Percutaneous aortic valve replacement, University, Vascular disease, Peripheral artery disease, Organization, Medtronic, EVAR, Endovascular aneurysm repair

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced the appointment of Mike Mathias as the company’s Chief Commercial Officer, effective immediately.

Key Points: 
  • Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced the appointment of Mike Mathias as the company’s Chief Commercial Officer, effective immediately.
  • With a distinguished 30-year career in leading commercial organizations within the cardiovascular arena, Mike brings a wealth of experience and a proven track record of success to Endologix.
  • Mike is uniquely qualified to lead our global commercial team and continue the strategic development of our commercial plans.
  • In response to his new role, Mike Mathias shared, "Joining Endologix at such a critical juncture is an honor.

Shape Memory Medical Completes $38 Million in Financing to Advance Endovascular Embolization

Retrieved on: 
Monday, March 4, 2024
Biotechnology, General Health, Medical Devices, Health, Cardiology, HBM, Blood, FDA, Food, IDE, Rupture, Death, Cayman, Safety, Abdominal aortic aneurysm, Memory, AAA, Ruppel, EVAR, Aneurysm, Research, Pharmaceutical industry

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced today that it has completed $38 million in Series C financing led by Earlybird Venture Capital and with the participation of new and existing investors, including HBM Healthcare Investments (Cayman) Ltd., WexMed II LLC, HBM-Medfocus LLC, and Emergent Medical Partners II, L.P..

Key Points: 
  • Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced today that it has completed $38 million in Series C financing led by Earlybird Venture Capital and with the participation of new and existing investors, including HBM Healthcare Investments (Cayman) Ltd., WexMed II LLC, HBM-Medfocus LLC, and Emergent Medical Partners II, L.P..
    “With this financing, we are well positioned to accelerate the clinical and market development of shape memory polymer technology for aortic and peripheral vascular markets,” said Ted Ruppel, president and CEO of Shape Memory Medical.
  • “The funds will support the execution of the AAA-SHAPE Pivotal Trial, a randomized controlled study comparing EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR.
  • The Company’s proprietary shape memory polymer is a low-density, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus.
  • Thom Rasche, Partner at Earlybird Venture Capital and the newest addition to the Shape Memory Medical Board commented, “Shape Memory Medical’s approach to embolization is highly differentiated.

Nectero Medical Announces Initiation of Phase II/III Clinical Trial of the Nectero EAST® System for Treatment of Small- to Medium-Sized Abdominal Aortic Aneurysms

Retrieved on: 
Thursday, January 18, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Patient, Rupture, Associate, EVAR, University, AAA, Risk, PGG, Division, Safety, Medicine, Hospital, Collagen, Clinical trial, Elastin, Growth, Pharmaceutical industry

The Nectero EAST System is a single-use, endovascular system comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG).

Key Points: 
  • The Nectero EAST System is a single-use, endovascular system comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG).
  • The system delivers PGG locally into the aneurysmal wall, where it can bind to elastin and collagen to potentially strengthen the aortic vessel wall and reduce the risk of further degradation.
  • “The Nectero EAST System aims to be the first proven early intervention therapy for small- to mid-sized AAA,” commented Jack Springer, President and Chief Executive Officer of Nectero Medical.
  • “Initiation of our randomized clinical trial is a significant milestone in our journey to bring this potentially transformative therapy to AAA patients.”

Vivasure Medical Announces First Patients Treated with PerQseal Elite Closure Device System

Retrieved on: 
Tuesday, December 12, 2023
Cardiology, Radiology, Surgery, General Health, Health, Medical Devices, Health Technology, Clinical Trials, TAVR, Safety, Calcium, Elite, ELITE, CAD, Aortic stenosis, Patient, Stenosis, EVAR, IDE, Trial of the century, TEVAR, Investigational device exemption

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.
  • Ph.D., at Erasmus University Hospital in Rotterdam, The Netherlands, as part of the company’s ELITE Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of PerQseal Elite.
  • PerQseal Elite leverages the legacy PerQseal system’s excellent safety profile and ease of use.
  • The company continues to enroll patients for its Investigational Device Exemption (IDE) clinical study for PerQseal and PerQseal+ in the United States.

Vivasure Medical Announces 100th Patient Enrolled in U.S. Pivotal Study

Retrieved on: 
Tuesday, November 14, 2023
Cardiology, Biotechnology, Medical Supplies, Surgery, Health, FDA, Medical Devices, Clinical Trials, TAVR, Safety, Food, CAD, Patient, Aortic stenosis, Stenosis, EVAR, IDE, Trial of the century, TEVAR, PATCH, Pharmaceutical industry

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.
  • The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward.
  • “We’re grateful to the one hundred patients who have been enrolled in this study to date and the brilliant physician investigators working to gather data about our technology,” said Andrew Glass, Chief Executive Officer of Vivasure Medical.
  • The PATCH pivotal study will enroll and follow up to 188 patients across the U.S. and Europe.

One-Year Results from the AAA-SHAPE Early Feasibility Study to be Presented at VEITH 2023

Retrieved on: 
Monday, November 13, 2023
General Health, Medical Devices, Other Health, Health, Medical Supplies, Abdominal aortic aneurysm, Interventional radiology, AAA, Patient, FDA, PMDA, CE, Auckland City Hospital, Blood, EVAR, Federal, IDE, MD, Memory, Doctor of Philosophy, Medical imaging

AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

Key Points: 
  • AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
  • Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and principal investigator for AAA-SHAPE Netherlands will present the data.
  • “We are encouraged by the one-year results and how shape memory polymer technology may ultimately influence sac behavior,” stated Professor Reijnen.
  • In the United States, IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use.

Saranas Successfully Completes Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support

Retrieved on: 
Monday, September 18, 2023
Science, Cardiology, Research, General Health, Health, FDA, Clinical Trials, Other Health, Bleeding, De novo, Morristown Medical Center, Classification, BARC, Henry Ford Health, Structural heart disease, PCI, Incidence, Henry Ford, Patient, Impella, TAVR, Early Bird, MCS, Early, EVAR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, III, Aortic stenosis, Food, Safety, Medical device, Birth control

The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.

Key Points: 
  • The Early Bird Bleed Monitoring System is the first and only FDA-approved bleed detection system.
  • Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants.
  • The Early Bird Bleed Monitoring System is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.

Shape Memory Medical Receives FDA IDE Approval to Initiate AAA-SHAPE, a Head-to-Head Trial

Retrieved on: 
Thursday, September 7, 2023
Medical Supplies, Medical Devices, FDA, Health, Other Health, General Health, Area studies, Technique, Columbia University Irving Medical Center, CE, Abdominal aortic aneurysm, University, Beth Israel Deaconess Medical Center, Aneurysm, Expansion, Section, Pivotal trial, Food and Drug Administration, Journal, AAA, PMDA, Patient, Blood, Randomized controlled trial, Mortality, IDE, EVAR, MPH, Memory, Vascular surgery, Food, Safety, Pharmaceutical industry, Medical imaging, EU, MD

Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm).

Key Points: 
  • Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm).
  • Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.
  • The investigational device, IMPEDE-FX RapidFill, incorporates the novel shape memory polymer, a proprietary, porous, polyurethane scaffold that is crimped for catheter delivery and self-expands upon contact with blood.
  • The AAA-SHAPE Pivotal Trial is preceded by the AAA-SHAPE early feasibility studies which enrolled a combined 35 patients in New Zealand and the Netherlands.

Endologix Announces 150th Patient Enrolled in JAGUAR Randomized Controlled Trial

Retrieved on: 
Tuesday, May 23, 2023
Surgery, Hospitals, Clinical Trials, Cardiology, Other Health, Biotechnology, Radiology, General Health, Pharmaceutical, Health, Gauge, JAGUAR, Metaphilosophy, Aortic aneurysm, AAA, Patient, Randomized controlled trial, Vascular disease, EVAR, Medical imaging

This randomized controlled trial is evaluating Endologix’s ALTO Abdominal Stent Graft System, comparing its effectiveness to other commercially available endovascular aneurysm repair (EVAR) devices in the treatment of abdominal aortic aneurysms (AAA).

Key Points: 
  • This randomized controlled trial is evaluating Endologix’s ALTO Abdominal Stent Graft System, comparing its effectiveness to other commercially available endovascular aneurysm repair (EVAR) devices in the treatment of abdominal aortic aneurysms (AAA).
  • The JAGUAR (ObJective Analysis to GaUge EVAR Outcomes Through Randomization) Study is a prospective, randomized, multi-center study, designed to enroll 450 patients at up to 60 sites.
  • "This milestone for Endologix underlines our dedication to clinical research and patient care," stated Matt Thompson, President, and CEO of Endologix.
  • “The JAGUAR trial, our second randomized study aimed at assessing comparative endograft performance, follows in the footsteps of our successful LEOPARD study.