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Catheter Design Articles & Analysis
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MedSource Labs, a class II medical device company headquartered in Minnesota, and Harsoria, an innovative manufacturer based in India, announced today the formation of Medsoria, their joint venture to expand production of peripheral IV catheters near Delhi, India. Together as Medsoria, the joint venture will increase production capabilities with a new 70,000 square feet (6,500 square meters) ...
The medical device industry is undergoing a transformative period marked by groundbreaking innovations and advanced materials. As healthcare continues to evolve, the need for devices that enhance patient outcomes while ensuring safety and reliability is more critical than ever. Among the various materials used in medical device design, polytetrafluoroethylene (PTFE tubing) has emerged as a ...
MedSource Labs recently launched a pilot internship program, sending engineering student Paul Borash to intern at India-based Harsoria, a partner company in the medical device industry. Paul, a student at the University of Montana, has demonstrated a strong interest in medical device engineering, particularly in the context of international collaboration. Paul was given the ...
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the publication of the results of its Cryocure-2 ultra-low temperature cryoablation (ULTC) study in patients with AF in the Journal of American College of Cardiology (JACC), Clinical Electrophysiology.1 The study prospectively enrolled 79 patients at ...
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, has named Eric S. Fain, MD as President and Chief Executive Officer effective immediately. The Board of Directors tapped Dr. Fain to build upon the foundation of innovative technology established over recent years and accelerate the progression of product development ...
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the global commercial availability of the Shockwave M5+ peripheral IVL catheter after receiving both CE Mark and U.S. Food and Drug Administration (FDA) clearance. The Shockwave M5+ catheter, which has been in limited launch ...
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 ...
Imperative Care, Inc. announced today that the first patient has been enrolled in the Imperative Trial. This prospective, multi-center clinical trial is the first study designed to evaluate the clinical benefits of direct aspiration for the treatment of ischemic stroke with the Zoom 88 Large Distal Platform, which is currently FDA cleared for neurovascular access. Additionally, the trial will ...
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 ...
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), today announced successful first-in-human use of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic VT. The two-hour mapping and ablation procedure was performed by Dr. Tom De Potter, MD, Associate Director, Cardiovascular Center ...
JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its TrilogyTM Heart Valve System for the treatment of both aortic regurgitation (AR), also known as aortic ...
Nipro Medical Corporation (NMC), a leading Renal, Medical, Surgical, and Interventional Radiology products manufacturer, announces the creation of a Vascular Division in the U.S. The division will include several cutting-edge technologies, innovative vascular and cardiovascular products to provide clinicians with procedural and imaging solutions that enhance patient care. To support the new ...
JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf toVice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve with over 30 years of experience in themedical device industry ...
Imperative Care, Inc. today announced that it has completed the initial closing of a Series C financing of $85 million to support the commercial launch of the company’s portfolio, which is composed of the latest advances in neurovascular devices treating ischemic and hemorrhagic strokes. The round was co-led by new investors Ally Bridge Group and Bain Capital Life Sciences. Existing ...
Imperative Care, Inc., a company singularly dedicated to answering unsolved problems in stroke, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ZOOM™ Aspiration System – a family of products designed to facilitate clot removal during ischemic stroke. The ZOOM Aspiration System includes the ZOOM Reperfusion Catheters, ZOOM Aspiration ...
Imperative Care, Inc., a company singularly dedicated to finding answers to unsolved problems in stroke, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its first family of access catheters, designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke and other brain blood vessel conditions. “Recognizing ...
Tempe-based interventional nephrologists Randy Cooper, MD and Umar Waheed, MD, and their team at SKI Vascular Center, this week became the first ambulatory surgical center in the US to create a percutaneous arteriovenous fistula (AVF), using the Ellipsys® Vascular Access System, a game-changing innovation for patients with End-Stage Renal Disease (ESRD). The recently FDA-approved Ellipsys ...
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, announced today it has hired three additional team members to support the advancement of its intra-aortic heart pump, AortixTM, for use in NYHA Class III-IV heart failure patients. Patricia DaSilva, Margo Fendrich, and Aaron Stone will focus on product development and ...
Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, today announced that its AortixTM device won the MedTech Breakthrough Award for "Best Overall Medical Device Product." MedTech Breakthrough is an independent organization that recognizes the top companies, technologies and products in the global health and medical ...
Anuncia, Inc., a privately-held company focused on better treatment of hydrocephalus and cerebrospinal fluid dysfunctions, announced, today, the successful first-in-human implantation of its Alivio ReFlow™ Ventricular System for treatment of hydrocephalus at Boston Children’s Hospital. This announcement comes on the heels of receiving the EU CE Mark and US FDA Clearance of Alivio ...