guiding catheter News
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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 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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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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Lungpacer Medical Accelerates Pivotal Clinical Study with AeroPace™ System
Lungpacer Medical, a leading medical device innovation company, today announced the introduction of the AeroPace™ System, a next generation product, into the RESCUE 3 pivotal clinical study studying faster ventilator independence. Lungpacer is dedicated to natural breathing by developing minimally invasive technologies designed to help patients wean off mechanical ventilation and breathe on ...
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1st Successful Heart Tumor Removal Without Open Heart Surgery
EchoPixel has once again contributed to a pioneering procedure at CentraCare – St. Cloud Hospital with the first team to remove a heart tumor without invasive open heart surgery using the novel AlphaVac catheter. Previously CentraCare had been the first to use EchoPixel’s 4D hologram technology to conduct the WATCHMAN implant, which is a one-time, minimally invasive procedure ...
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Minimally Invasive Ellipsys System Creates Fused, Permanent Vascular Access for Dialysis
A new case report published in the Journal of Vascular Surgery provides one of the first known opportunities to directly visualize the permanent and fused connection (anastomosis) that is created with the minimally invasive Ellipsys® Vascular Access System. The Ellipsys System, made by Avenu Medical, creates a type of dialysis access known as a percutaneous arteriovenous fistula (pAVF) for ...
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FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation
FARAPULSE Inc. today announced the first patients were treated in the ADVENT Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation (AF). AF is a heart rhythm disorder that affects nearly 6 million Americans and makes ...
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Two-year Ellipsys data featured at annual Controversies in Dialysis Access (CiDA) Meeting
A landmark two-year follow-up study on the Ellipsys® Vascular Access System was highlighted at the annual Controversies in Dialysis Access (CiDA) meeting, one of the premier dialysis access medical conferences in the world. The Ellipsys System from Avenu Medical is a non-surgical alternative to creating vascular access for end-stage renal disease (ESRD) patients who require hemodialysis. It ...
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Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation
Acutus Medical, Inc. (Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the initiation of AcQForce PFA-CE, a new clinical study that will evaluate the safety and performance of the company’s focal force sensing Pulsed Field Ablation (PFA) catheter and system in combination with ...
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New Study Shows Advantages of Ellipsys System in Safely and Quickly Creating Reliable Dialysis Access
A new study shows significant benefits of the Ellipsys Vascular Access System in easily and safely creating durable vascular access for end-stage renal disease (ESRD) patients who require hemodialysis. It also offers a standardized process for using the minimally invasive technology that other physicians can follow to reproduce the results, which “will make it easier for more practitioners ...
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Ellipsys System Offers Significant Advantages for Creating Dialysis Access, Physicians Say
The Ellipsys® Vascular Access System enables patients with kidney failure to start dialysis treatment sooner with fewer procedures, complications and interventions compared to surgery, according to several leading physicians who spoke at the recent meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN). Interventional radiologist Jeffrey Hull, M.D., was awarded ...
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Medtronic to Acquire Avenu Medical
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the planned acquisition of Avenu Medical, a privately held medical device company based in San Juan Capistrano, Calif. focused on the endovascular (minimally invasive) creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. Terms of the transaction were not ...
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BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announces the designation of a new reimbursement code for the CardiAMP® Cell Therapy procedure to transplant autologous bone marrow cells to treat heart failure from the U.S. Center for Medicare and Medicaid Services (CMS). This new CMS code to ...
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BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: NCT02438306), just ...
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Novel Securement Device Making Inroads
AVA Scientific Meeting 2019 highlights key opportunities for improvement in vascular access from process bundles to emerging new products Introduction Acknowledgment of the importance of the vascular access nurse and team were obvious at this year’s Association for Vascular Access (AVA) Annual Scientific meeting. When Ramzy Nasrallah took over as CEO for the Association of Vascular Access ...
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