balloon catheter News
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Concept Medical is Granted CE Certification for Sirolimus Coated MagicTouch Group of Products.
Concept Medical B.V. with its headquarters in Tampa, Florida has announced that on 16th October 2019, they have received the CE certification for their MagicTouch group of products. The CE certified products/brands are as listed below: MagicTouch – PTA (Sirolimus Coated PTA Balloon Catheter) for peripheral arterial disease MagicTouch – ED (Sirolimus Coated Balloon Catheter) for ...
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Neurescue Announces Appointment of Medtronic Veteran Mette-Marie Harild to Company’s Board of Directors
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a clinical-stage medical device company bringing to market the world’s first computer-aided balloon catheter for aortic occlusion, today announced that medical device industry veteran Mette-Marie Harild has been appointed to the Neurescue board of directors. Most recently the regional vice president of Medtronic’s largest sub-region in ...
By Neurescue
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Q’Apel Medical announces FDA clearance for Walrus Balloon Guide Catheter.
In the neurovascular space where speed, reliability, and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, with its 087 ID, marks a big step forward in balloon guide catheter technology and for stroke patients worldwide. “I expect its introduction will be welcomed by neurovascular physicians ...
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Q’Apel Medical Welcomes Jodie Fam, Vice President and General Manager, International
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, is pleased to announce and welcome Jodie Fam as Vice President and General Manager, International. Jodie will be responsible for the leadership and development of International Sales for Q’Apel. Jodie brings more than 20 ...
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Q’Apel Medical Welcomes Thomas Berryman, Chief Financial Officer
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, is pleased to announce and welcome Thomas Berryman as Chief Financial Officer. Tom has extensive experience in bringing venture funded medical technology companies from initial startup through product commercialization, revenue ...
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Showcase
Wired: This startup wants to stop deaths from cardiac arrest?
In April 2013, final-year Danish medical student Habib Frost was called out to an emergency: a four-month old girl had just suffered cardiac arrest. Frost’s team tried defibrillation, but to no avail. Immediately after, the team was called out again: another case of cardiac arrest, this time a woman in her 30s. Once again, Frost was powerless to save her life. “I felt ...
By Neurescue
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MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions.
Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes “The ...
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Showcase
Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...
By Neurescue
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Soundbite Medical Announces Issuance Of A Fifth U.S. Patent Covering Novel Active Balloon Devices Intended For Plaque Modification Of Calcified Arteries
Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued US patent No. 11,179,169, entitled “Device for delivering mechanical waves through a balloon catheter”. The ...
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Kardium performs first cases with the Globe® Positioning System
VANCOUVER, British Columbia – Kardium is pleased to announce the first clinical use of the Globe Positioning System (GPS™) – the new 3D mapping and navigation feature of its flagship product, the Globe® Mapping and Ablation System. The Globe System is the most complete solution for the treatment of atrial fibrillation (AF) – the world’s most common heart rhythm ...
By Kardium Inc.
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Q’Apel Medical Raises $22 Million to Grow Highly Innovative Neurovascular Access Platform & Scott Huennekens joins Board of Directors.
Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today it has raised $22 Million in Series C funding. The round included River Cities Capital, Soleus Capital and incumbent investor, Research Corporation Technologies (RCT). Scott Huennekens, former Chairman, CEO and ...
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Q’Apel Medical Announces Move to New Headquarters Facility in Fremont, CA
New 35,000 square foot Facility will support the company’s growth and OUS expansion Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today that it will relocate its existing headquarters into a new building at 4245 Technology Dr, Fremont, CA, 94538. The 35,000 ...
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Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA study.
Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today the enrollment of the first patient in its EXPANSE PTCA study (NCT04985773) at the Cardiology Associates of North Mississippi in Tupelo, Mississippi. The study will be conducted in the United States with the objective to evaluate safety and effectiveness of the Lacrosse NSE ...
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B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent Please ReX Drug Coated PTCA Balloon Catheter
B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial for the B. Braun SeQuent Please ReX Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019. This announcement furthers the ...
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Q’Apel Medical announces first-in-human case with Wahoo.
Q’Apel Medical, a neurovascular medical device company, today announced it successfully completed the first-in-human case with the Wahoo access catheter, utilizing the next-generation SelectFlex technology. The procedure was performed by Raymond Turner, M.D., at Prisma Health in Greenville, South Carolina. The Wahoo access catheter contains proprietary SelectFlex variable stiffness ...
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Q’Apel Medical Launches Armadillo – A New Radial Artery Access Platform to Meet the Needs of Physicians and Patients
Nationally there is a trend moving towards radial artery access versus femoral artery access for endovascular procedures and Q’Apel Medical is leading the way. Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today the launch of the Armadillo Radial Access ...
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IlluminOss Medical Receives Clearance to Expand Clinical Indications in the U.S.
IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that the IlluminOss Photodynamic Bone Stabilization System has received additional clinical clearance and is now indicated by the U.S. Food and Drug Administration (FDA) for use in skeletally mature patients in the treatment of traumatic, ...
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Preliminary Data Presented from First U.S. Clinical Trial of IlluminOss Medical`s Photodynamic Bone Stabilization System
IlluminOss Medical, a privately-held, commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that Richard Terek, M.D., presented the first preliminary data from its U.S. pivotal clinical trial at the recent Musculoskeletal Tumor Society (MSTS) Meeting in Detroit. The IlluminOss System is the world’s only system of its kind which ...
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IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss Bone Stabilization System
IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease. ...
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CD Bioparticles Introduces Hydrophilic Coatings for Medical Applications
CD Bioparticles, a leading manufacturer and supplier of various drug delivery products and services, recently introduced hydrophilic coatings and related services for medical applications, which can be used within interventional medical devices of the cardiovascular, circulatory, nervous, urinary, and vascular system. Functional medical coatings are a class of interface materials applied to the ...
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