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Balloon Catheters Articles & Analysis
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Its state-of-the-art facilities and adherence to FDA guidance documents and ISO standards guarantee accurate and reliable testing results, enabling clients to bring safe and effective balloon catheter products to market. These comprehensive balloon catheter testing services can assess the performance and safety of medical ...
BySTEMart
In addition, hydrophilic coatings can be used within interventional medical devices of the cardiovascular, circulatory, nervous, urinary, and vascular system, which include inner and outer surfaces of stents, separators, lenses, guide wires, needles, vascular access, implants, urinary catheters, balloons, and catheters. CD Bioparticles offers a ...
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with ...
The study will be conducted in the United States with the objective to evaluate safety and effectiveness of the Lacrosse NSE (Non-Slip Element) ALPHA coronary dilatation balloon catheter during percutaneous coronary intervention (PCI) in patients with stenotic coronary arteries. The Lacrosse NSE ALPHA has unique nylon elements on the exterior of the ...
Second Heart Assist, Inc: Second Heart Assist, Inc. has developed both a catheter-based circulatory assist pump and a wireless power chronic implant aortic stent pump to aid patients with heart failure and reverse cardio-renal dysfunction. ...
The company’s portfolio comprises two core products, the Walrus Balloon Guide Catheter (BGC) system, and the Wahoo Control™ Catheter hybrid access system. Q’Apel’s Walrus BGC is specifically designed to assist doctors in performing mechanical thrombectomy procedures on stroke patients. Unlike existing ...
Q’Apel’s portfolio comprises three products, the Walrus Balloon Catheter System, the Wahoo Hybrid Access System and Armadillo Radial Access System. Before Walrus came along, balloon-based variable stiffness catheters brought all manner of technological constraints. ...
The company’s portfolio comprises two core products, the Walrus Balloon Guide Catheter (BGC) system, and the Wahoo Control™ Catheter hybrid access system. Q’Apel’s Walrus BGC is specifically designed to assist doctors in performing mechanical thrombectomy procedures on stroke patients. Unlike existing ...
The NEURESCUE device is the world’s first intelligent balloon catheter for aortic occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the aorta to ...
Q’Apel’s core portfolio comprises two products, the Walrus Balloon Catheter System and the Wahoo Hybrid Access System. Before Walrus came along, balloon-based variable stiffness catheters brought all manner of technological constraints. ...
The ReFlow system is comprised of a subcutaneous flusher component and a ventricular catheter with a membrane relief feature close to the proximal end. The device is located under the scalp, much like a cerebral spinal fluid (CSF) shunt. ...
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. ...
Braun SeQuent Please ReX Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019. ...
The company’s portfolio comprises two core products, the Walrus Balloon Guide Catheter (BGC) system, and the Wahoo Control™ Catheter hybrid access system. Q’Apel’s Walrus BGC is specifically designed to assist doctors in performing mechanical thrombectomy procedures on stroke patients. Unlike existing ...
(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 ...
It is a powerful 122-electrode mapping and ablation system that combines best-in-class technologies into a single catheter, uniting the rapid pulmonary vein isolation (PVI) of balloon catheters, the flexibility of single-tip catheters, and the high-definition mapping of multi-electrode mapping catheters. The new ...
Building on that success, we recently integrated VeraForm into our APBI program with the SAVI® brachytherapy catheter system. APBI is increasing in popularity among patients across the country, particularly given that less fractions mean less visits for them. ...
The Wahoo access catheter contains proprietary SelectFlex variable stiffness technology that allows the physician to control the level of flexibility or support that the catheter provides at any given moment during a clinical case. This advancement in catheter technology aims to simplify the neurovascular access platform in clinical cases, put ...
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 Erectile Dysfunction MagicTouch – AVF (Sirolimus Coated PTA Balloon ...
HL: I’ve been working in the field since the 1980s when we patented and developed a predictably compliant balloon that could be used with cardiovascular balloon catheters. We built a modest business around that. ...