Search Results for 'aaa'
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Cardiovascular | Surgical
Shape Memory Medical Nabs IDE Nod for AAA-SHAPE Head-to-Head Trial
Will determine safety and effectiveness of IMPEDE-FX RapidFill device to improve abdominal aortic aneurysm sac behavior.Sam Brusco, Associate Editor 09.07.23
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Cardiovascular
Shape Memory Medical Completes Enrollment in AAA-SHAPE Early Feasibility Study
Trial is evaluating the application of a proprietary shape memory polymer in improving aneurysm sac regression rates following EVAR.Michael Barbella, Managing Editor 09.26.22
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Cardiovascular
Endologix's AFX2 Endovascular AAA System Earns EU Nod
Certified under the new EU-MDR standard.Sam Brusco, Associate Editor 08.08.22
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Cardiovascular
Dyad Medical’s Libby IAAA Cleared by FDA
Offers image analysis used for viewing and quantifying Intravascular Optical Coherence Tomography (IVOCT) images.Charles Sternberg, Associate Editor 02.24.22
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GORE Reports First Use of the EXCLUDER Conformable AAA Endoprosthesis
Cases successfully performed in Brooklyn, N.Y., and Houston.Michael Barbella, Managing Editor 05.07.21
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Cardiovascular
Shape Memory Medical Enrolls First Patient in AAA-SHAPE Study
The trial will enroll 15 patients outside the United States.Business Wire 10.26.20
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Terumo Acquires Aortica Corporation
Deal is expected to support the continued growth of Terumo's Vascular Graft Business and contribute to personalized aortic therapy.Terumo Corporation 11.20.19
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Cardiovascular
Medtronic Stent Graft System Receives FDA Breakthrough Device Designation
Developed to treat thoracoabdominal aortic aneurysm.Globe Newswire 10.08.19
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Endologix Forges Distributor Agreement With Boston Scientific for the Chinese Market
The agreement includes distribution rights to Endologix’s current EndoVascular Aneurysm Repair and Endovascular Aneurysm Sealing products.Business Wire 10.02.19
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Cardiovascular
First U.S. Patient Receives GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL
Data shows 100 percent successful deployment and no fractures at 30-day follow-up in European Registry.Business Wire 08.30.19
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Cardiovascular
FDA Approves the GORE TAG Conformable Thoracic Stent Graft With ACTIVE CONTROL
The device and new delivery system optimize TEVAR outcomes in complex aortic anatomy.Business Wire 07.01.19
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Cardiovascular
Gore Introduces GORE TAG Conformable Thoracic Stent Graft With Reduced Profiles in Europe
Reduced profiles on most commonly used sizes allow the device to be introduced through a smaller sheath.Business Wire 02.28.19
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Endologix Appoints Chief Commercial Officer
New hire brings to the position more than 20 years of commercial, sales and marketing, and business development experience in the medtech sector.Business Wire 02.22.19
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Patient Monitoring
FDA Clears Masimo's Respiration Rate from the Pleth on Spot-Check Fingertip Pulse Oximeter
Masimo MightySat Rx, now also indicated for use at home, is the first fingertip pulse oximeter with SET and the first to measure respiration rate.Business Wire 01.28.19
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Cardiovascular | Surgical
FDA Approves Cardinal Health's INCRAFT AAA Stent Graft System
The flexible endovascular aneurysm repair system treats infrarenal abdominal aortic aneurysms.Cardinal Health 11.29.18
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Cardiovascular
First European Patient Receives Implant of GORE EXCLUDER Conformable AAA Endoprosthesis
Patient also enrolls in post-market registry, will assess safety and abdominal aortic aneurysm treatment success.Business Wire 10.17.18
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Cardiovascular | Surgical
FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall
The AFX Endovascular AAA System recall was due to Type III endoleaks after endovascular aneurysm repair.Business Wire 10.08.18
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Cardiovascular
Gore Announces Successful Patient Implant of Endovascular Stent Graft for the Ascending Aorta
Investigational device is an off-the-shelf endovascular solution for treating Type A dissections of the ascending aorta.Business Wire 09.25.18
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Cardiovascular
Endologix Appoints Chief Operations Officer
New hire brings 24 years of experience to the position.Business Wire 09.17.18
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Cardiovascular | Surgical
Gore's Molding & Occlusion Balloon for Endovascular Aortic Repair Earns FDA, Japanese, and EU Nods
New balloon addresses EVAR stent graft seal and temporary vessel occlusion challenges.Business Wire 08.23.18
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Cardiovascular
Gore Announces First In-Human Use of GORE TAG Conformable Thoracic Stent Graft
New delivery system provides controlled, predictable placement of highly conformable and time-tested stent graft.Business Wire 08.10.18
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Cardiovascular
Endologix Reports Positive One-Year Results from the Ovation LUCY Study
Data show that women had similar outcomes to men after treatment with the ultra-low profile Ovation device.Business Wire 08.09.18
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Endologix Appoints Chief Quality Officer
Latest hire brings to the company almost 30 years of executive leadership and quality expertise.Business Wire 08.03.18
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Endospan Elects a Board Member
New board member is president and CEO of Veniti.Business Wire 06.22.18
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Cardiovascular
Endologix Appoints CEO
New chief executive has served as the company’s chief operating officer since October 2017.Business Wire 06.11.18
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Cardiovascular
Endovascular Aneurysm Sealing With Nellix System Linked to Higher Survival Than Traditional Repair
Study shows patients with larger aneurysms treated with EVAS had half the mortality at three years.Business Wire 05.31.18
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Cardiovascular
Endospan Appoints CEO
Former Endologix exec spearheading CE mark registration of NEXUS Stent Graft System for aortic arch disease.Business Wire 04.11.18
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Cardiovascular
Endologix Enrolls First Patient in Study of the Nellix EndoVascular Aneurysm Sealing System
The system has received a CE Mark and is commercially available in various markets, including Europe.Business Wire 04.04.18
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Cardiovascular
Endologix Inc. Completes Patient Enrollment in the ELEVATE IDE Clinical Study
Study will evaluate the safety and effectiveness of the Alto Abdominal Stent Graft System for the repair of infrarenal AAAs.Business Wire 02.27.18
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Cardiovascular
First Patient Enrolled in Investigational Study of the GORE EXCLUDER Conformable AAA Endoprosthesis
Trial is investigating the safety and effectiveness of a stent graft system designed to provide endovascular aneurysm repair.Business Wire 01.29.18
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Cardiovascular
Endologix Receives IDE Approval for the EVAS2 Confirmatory Clinical Study
Trial will evaluate the Nellix EndoVascular Aneurysm Sealing System.Business Wire 10.23.17
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Cardiovascular
Aortica Corp. Reports Successful Results of EVAR Patients Using Automated Case Planning Software
Software simplifies the process of aligning and placing the endograft in patients.Business Wire 10.10.17
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FDA Approves Medtronic’s Stent Graft System for Short Neck Anatomies
New indication expands treatment options for AAA patients with hostile neck anatomy.Medtronic plc 10.09.17
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Endologix Announces CE Mark Approval for the Nellix EndoVascular Aneurysm Sealing System
Company to begin clinical study in the United States to evaluate the product's safety and effectiveness.Business Wire 10.06.17
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Endologix Announces Collaboration Agreements with Japan Lifeline
Agreements pertain to the development and distribution of endovascular stent graft systems.Business Wire 09.27.17
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Cardiovascular
Endologix Announces Positive Clinical Results from the LEOPARD Clinical Study
Study was initiated in 2015 and has since randomized 458 patients.Business Wire 08.31.17
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Gore Announces First-in-Human Use of GORE TAG Conformable Thoracic Stent Graft
New delivery system provides controlled and predictable placement of Gore’s stent graft.Business Wire 07.28.17
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Cardiovascular
Endologix Reports Positive Clinical Data from the Ovation LUCY Study
First prospective clinical trial to evaluate endovascular aneurysm repair in women.Business Wire 06.19.17
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GORE EXCLUDER Iliac Branch Endoprosthesis Approved in Japan
Gore designed All-in-One System to preserve iliac artery blood flow in patients with iliac or aortoiliac aneurysms.Business Wire 06.09.17
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Cardiovascular
First Patient Enrolled and Treated in Lombard Medical's ALTITUDE Registry for the Altura Stent Graft
Trial will evaluate the use of the Altura Endograft System in 1,000 patients in typical clinical-use conditions.Business Wire 05.26.17
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Cardiovascular
Endologix Announces Enrollment of First Patients in ELEVATE IDE Clinical Study
First procedure was performed in New Mexico.Business Wire 04.12.17
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Cardiovascular | Digital Health | Electronics | Patient Monitoring | Software & IT
FDA Clears Medtronic's Insertable Cardiac Monitor with TruRhythm Detection
Device delivers improved accuracy and streamlined data for clinicians.Medtronic 03.13.17
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Cardiovascular
Study Shows Fenestrated Endovascular Aneurysm Repair Demonstrates Excellent Outcomes
Ongoing study evaluates physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms.Business Wire 03.06.17
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Cardiovascular
Endologix Completes Patient Enrollment in the Ovation LUCY Study
First prospective study evaluating EVAR in a female population.Endologix Inc. 02.23.17
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Cardiovascular
Lombard Medical Completes First 15 Cases in Japan for IntelliFlex LP Delivery System
IntelliFlex is used in conjunction with the Aorfix endovascular stent graft.Lombard Medical Inc. 02.14.17
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Verily Announces $800 Million Investment by Temasek
Companies to collaborate on expansion of Verily’s programs outside of the United States.Business Wire 02.02.17
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Endologix Reports Positive Three-Year Results from the Ovation European Post Market Registry
Registry included a total of 501 patients enrolled across 30 European centers.Endologix Inc. 01.31.17
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R&D & Design
Aortica Appoints Three New Members to Scientific Advisory Board
Company expands number of board members from three to six.Business Wire 01.18.17
