Cnovate Medical B.V. Obtains MDR Certification for Class III Medical Device, PTCA
Amersfoort, 20, September 2023 - Today, Cnovate Medical B.V. (hereinafter referred to as "Cnovate") announced that successfully completed the certification process of the European Medical Device Regulation MDR (2017/745) for Helix Semi-compliance coronary dilatation catheter and Vecchio Non-compliance coronary dilatation catheter, and received European Medical Device Regulation (MDR) certification for these two Class III (highest risk) medical devices.
The CE approval of MDR for PTCA (Helix and Vecchio) indicates that international medical device regulatory authorities have recognized Cnovate Medical Quality Management System and effectiveness and safety of Helix and Vecchio. Cnovate medical will continue to focus on innovative research and development, providing more high-quality medical devices for patients worldwide.
“Obtaining the MDR certificate for these Class III medical devices, Cnovate medical will continue emphasizing quality and safety of current product lines and medical device’s innovation and development in the future’. Stephen Lee, General manager commented:’ the new MDR certificate approved the Helix and Vecchio shelf life from 2 years to 3 years that will benefit our business partners placing orders, and the PTA MDR certificates are expected obtained soon’.
The approved Helix balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Helix (Rx type) device is a coronary dilatation catheter designed for easy guidewire exchange. The catheter working length is 140cm. Balloon diameters range from Ø1.0mm to Ø 4.0mm. The balloon material is made of a semi-compliant Pebax material for diameter 1.0mm to 4.0mm with a rated burst pressure of 14 atmospheres.
The approved Vecchio balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. And balloon dilatation of a stent after implantation (balloon models 2.0mm-5.0mm only). The Vecchio Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from Ø2.0mm to Ø5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0-4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively.
/uploadfiles/Files/2023/10/20231016191153512.pdf