aneurysm News
-
Balt Receives CE Mark and Performs First-in-Man for the Silk Vista Flow Diverter
Balt (www.balt-corp.com) announced today it has received CE Mark Approval for its Silk Vista flow diverting stent to treat patients with unruptured intracranial aneurysms, enabling commercialization in over 30 countries in and around the European Union. Flow diverters are intended to divert blood flow away from an aneurysm, allowing the aneurysm to heal and reducing the risk of aneurysm rupture. ...
-
Cerus Endovascular Receives CE Mark Approvals for its Neqstent Coil Assisted Flow Diverter Designed to Treat Intracranial Aneurysms
Cerus Endovascular Ltd., a privatelyheld, commercial stage medical device company, today announced that it has received CE Mark approval for its Neqstent Coil Assisted Flow Diverter device, designed to treat intracranial aneurysms. Neqstent is designed to treat a range of aneurysm morphologies including wide-necked bifurcation and bifurcation aneurysms. Neqstent is an adjunctive intrasaccular ...
-
Balt Completes Enrollment in FIRST: A Multi-center, Prospective, International Study of Low Profile Silk Vista Flow Diverters
Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today announced enrollment in the FIRST study has been completed. The FIRST study is an observational, prospective, multi-center, international, single-arm study with the aim of ...
-
Cerus Endovascular Receives CE Mark Approval for its 021 Contour Neurovascular System
Cerus Endovascular Ltd., a privately held, commercial stage medical device company, today announced that it has received CE Mark approval for its 021 Contour Neurovascular System, compatible with smaller commercially available 021 microcatheters for the treatment of saccular intracranial aneurysms. The Contour Neurovascular System is a unique, fine mesh braid that is deployed across the neck of ...
-
Endospan receives CE mark for HORIZON EVAR system based on robust clinical and pivotal data to treat Abdominal Aortic Aneurysm (AAA)
Endospan, a pioneer in off-the-shelf EndoVascular Aortic Repair (EVAR), announced today that it has received CE marking for its HORIZON Stent Graft System to treat Abdominal Aortic Aneurysm (AAA). “HORIZON is a unique platform that can be used in a 14Fr single-sided approach, generally shortening and simplifying EVAR procedures,” said Kevin Mayberry, CEO. “HORIZON is supported ...
-
Cerus Endovascular Successfully Completes Series B Financing and Receives U.S. FDA Approval for its First Microcatheter
Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has now successfully completed its Series B financing having raised a total of $19.0 million from current and new institutional investors since commencement of the round in July 2018. The company also reported that it has received approval from the U.S. Food and Drug Administration (FDA) ...
-
Axial3D and BIOMODEX Announce Strategic Partnership
Axial3D, an award-winning medical imaging technology company, headquartered in Belfast has announced a partnership with BIOMODEX®, the leader in biorealistic haptic simulators for physician training and rehearsals. The partnership will enable Biomodex to speed the production of 3D-printed brain aneurysm models by reducing the time it takes to transform 2D medical images to 3D visuals. An ...
By Axial3D
-
Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective ...
-
Cerus Endovascular Announces the First Ever Robotic Assist Intracranial Implant of its Contour Intrasaccular Device
Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced the first ever robotically assisted intracranial implant of its Contour intrasaccular device. The groundbreaking procedure was completed at the King Edward Memorial Hospital, Mumbai, by renowned neurosurgeon, Dr. Nitin Dange and was performed on a Middle Cerebral Aneurysm with a 7mm Contour device. ...
-
Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System
Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the Contour Neurovascular System™, indicated for the treatment of intracranial aneurysms. The IDE approval follows the receipt of Breakthrough ...
-
Balt Appoints Jeffrey Sachs Chief Legal & Compliance Officer
Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today announced the appointment of Jeffrey Sachs as the Company's Chief Legal & Compliance Officer. Jeffrey Sachs joins the Balt team with over 25 years of experience in ...
-
Endospan elects Jeff Elkins as a director
Endospan, a pioneer in off-the-shelf endovascular repair of Aortic Arch Disease including aneurysms and dissections, today announced that it has elected Jeff Elkins to its board of directors. Elkins has been President and CEO of Veniti Inc. since July 2015. Previously, Elkins was COO and earlier CEO of Aptus Endosystems, acquired by Medtronic; and, founding COO of FlowMedica, acquired by ...
-
Cerus Endovascular and Balt Enter Strategic Distribution Agreement for Innovative Neurovascular Devices to Treat a Range of Intracranial Aneurysms
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company and AB Medica Deutschland Verwaltungs GmbH, a wholly owned subsidiary of Balt, today announced that they have entered into a strategic distribution agreement providing AB Medica with the exclusive rights to market and sell the newly CE marked Contour Neurovascular System™ and the Neqstent Coil Assisted Flow ...
-
Rapid Medical Marks First Procedures with Numen Coil from MicroPort Scientific
Rapid Medical, a leading developer of advanced neurovascular devices, announces the expansion of its portfolio in the United States and the first Numen™ coil embolization procedure. Rapid Medical now has an exclusive distribution agreement with MicroPort NeuroTech, a subsidiary of MicroPort Scientific Corporation. MircoPort’s global presence offers nearly 300 medical solutions to ...
-
Endospan Enters Into Strategic Distribution Agreement With CryoLife
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, today announced it has entered into strategic distribution and credit facility agreements with CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease. Under the terms of the agreement, CryoLife will have exclusive European distribution rights to NEXUS™, the first ...
-
Cerus Endovascular Receives CE Mark Approval for its Contour 021 device
Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has received CE Mark approval for its state of the art CerusEndo MC 021 microcatheter, designed to allow physicians to access tortuous neurovasculature and deliver therapeutic devices to intended targets. “We remain committed to meeting the ever-increasing needs of the interventional ...
-
Thermo Fisher Scientific Announces Collaborations to Meet Unmet Clinical Needs in Biomarker Discovery and Characterization
Thermo Fisher Scientific, the world leader in serving science, today announced new collaborations of the Thermo Fisher Precision Medicine Science Center (PMSC) with AstraZeneca and the University of Nebraska Medical Center as part of its ongoing development of innovative solutions for unmet needs in clinical biomarker discovery. The new alliances strengthen the PMSC's mission of creating ...
-
FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. The FDA’s Breakthrough Device Designation Program is intended to provide timely access to medical devices that have the potential to provide a more effective ...
-
Endologix Launches ALTO™ Abdominal Stent Graft System in Europe
Furthering its mission to transform the treatment of aortic disorders, Endologix LLC today announced the first implant of its ALTO™ Abdominal Stent Graft, commencing the European commercial release of the recently CE Mark approved endograft. “We are pleased to expand the product launch to include Europe, making ALTO available to our physician partners and patients there as well as in ...
-
Endospan Enrolls First Patient in the TRIOMPHE IDE Study
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, announces the first implant of the NEXUS™ Aortic Arch Stent Graft System on a patient with a thoracic aortic aneurysm as part of the TRIOMPHE Study in Norfolk, Virginia, January 11, 2021. The TRIOMPHE Study is a multi-arm, multi-center, non-randomized, prospective, clinical study to evaluate the safety and ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you