VenusP-Valve™ System

The VenusP-Valve System is the first self-expanding nitinol stent for pulmonary valve in Europe known to Venus Medtech. The VenusP-Valve System was designed at 28-36 mm for valve diameter specifically for large RVOTs. The intended purpose of VenusP-Valve is to replace the pulmonary heart valve with an artificial valve using a minimally invasive percutaneous approach, to treat right ventricular outflow tract (RVOT) dysfunction and specifically for the dilated outflow tracts to restore pulmonary valve function.

Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated. Septicemia, including active endocarditis. Recent myocardial infarction (< 30 days). Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Any Contraindication of extracorporeal assist. Evolutive or recent cerebral vascular accident (CVA). Obstruction of the central veins. Bleeding diathesis, coagulopathy, patient refusal of blood transfusion. Creatinine Clearance Calculator (CCR) <20mL/min. Pregnancy. Patients with known allergies to porcine materials. Patients who are breastfeeding.

Associated with transfemoral access and general anesthesia death. Cardiovascular or vascular injury, such as perforation or damage (dissection) of vessels, myocardium, or valvar structures, that may require intervention. Arrhythmia. Pericardial effusion/cardiac tamponade. Perforation or damage of vessels. Embolization: air or thrombus.Hematoma. Hemorrhage requiring transfusion. Hypertension/hypotension. Infection including endocarditis and septicemia. Systemic peripheral ischemia/nerve injury. Allergic dye reaction. Anesthesia reactions. Radiation injury. Fever……

Associated with the VenusP-Valve System  
Myocardial infarction. Arteriovenous fistula. Bleeding. Coronary artery compression. Device embolization requiring intervention. Device explant. Device migration or malposition requiring intervention. Device thrombosis requiring intervention. Emergency cardiac surgery. Endocarditis. Hemolysis. Hemolytic anemia. Important Information About Stent Fracture. In some patients, the wire frame (stent) of the VenusP-Valve System may fracture because of the forces it is exposed to in the body.In some cases, the fractured stent may not require any additional treatment. However, the patients should realize a fractured stent has the potential to become serious and could result in the need for another procedure. The doctor will decide the best treatment option. In the VenusP-Valve System CE Clinical Interim Report data, eleven (11) stent fractures (14.5%) have been identified, which did not affect the Valve functionality and no need for additional treatment.


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