Profile: Evalve Inc deals with the percutaneous repair of cardiac valves. Our Evalve MitraClip® system is designed with three major subsystems that include steerable guide catheter, clip delivery system, and Mitracli® device (implant). Our Evalve Mitraclip® system features a guide catheter, which is inserted into the femoral vein at the groin and provides access to the mitral valve, a clip to grasp and fasten together the valve leaflets, and a clip delivery system to deliver & deploy the Mitraclip® device. Our system focuses on the patients recovering from mitral valve surgery. Our percutaneous Evalve Mitracli® procedure does not require a chest incision or the use of a heart lung machine, and this helps the patients avoid the complications & long recovery time associated with surgery.
FDA Registration Number: 3005070406
9 Products/Services (Click for related suppliers)
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• AVM Micro Clip System |
• Guide Catheters |
• Heart Valve Repair Products |
• Intravascular Catheter Securement Device (FDA Code: KMK / 880.5210) An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin. |
• Mitral Regurgitation Reducing Systems |
• Proximal Femoral Fixation Implant Device (FDA Code: JDO / 888.3030) Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• Steerable (Magnetic) Catheter Or Guidewire System (FDA Code: NDQ / 870.1290) A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter. |
• Steerable Catheter (FDA Code: DRA / 870.1280) A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit. |
• Valve Surgery Retractor System |