Clinical Evidence

Regulatory conformity

CE marked as a Class IIb device under EU Regulation 2017/745, certified by DEKRA Certification B.V., notified body 0344. Tested to IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-2.

Mechanism of action

Controlled thermal energy causes endothelial denaturation and collagen contraction, producing wall thickening and fibrotic occlusion of the treated segment.

Stated clinical benefit

Resolution of the symptoms of chronic venous insufficiency, and venous leg ulcer healing, as set out in the manufacturer's Instructions for Use.

Published literature

A bibliography of peer-reviewed studies on endovenous radiofrequency ablation is available to healthcare professionals on request.

Indications

Intended use

Indication Endovascular coagulation of blood vessels in patients with superficial vein reflux; ablation and coagulation of great saphenous varicose veins of the lower extremity.
Patient population Adults with chronic venous insufficiency.
Intended users Physicians skilled in duplex ultrasound, vascular intervention and chronic venous insufficiency.
Site of use Operating theatre or procedure room with duplex ultrasound available.
Vessel calibre Target veins between 2 mm and 15 mm in diameter.

Certification

Certificate of record

Certificate6153864CE01 — EU Quality Management System Certificate
RegulationEU 2017/745, Annex IX Chapters I and III
Notified bodyDEKRA Certification B.V., Arnhem, Netherlands — ID 0344
ClassificationClass IIb — electrosurgical instruments; single-use radiofrequency surgery instruments
First issued7 April 2025
Current revision2 February 2026
Valid to1 April 2030
Manufacturer SRNCN-MF-000025983
EU representativeProlinx GmbH, Düsseldorf, Germany

Certification is held by the manufacturer, Zhejiang CuraWay Medical Technology Co., Ltd, and covers the device. The manufacturer is subject to periodic surveillance by the notified body. A copy of the certificate is available on request.

Important safety information

Contraindications and complications

Abbreviated. This summary does not replace the Instructions for Use, and any clinical decision should be made against the full document.

Contraindications

Thrombus in the venous segment to be treated
Acute thrombosis of the great saphenous trunk
Deep venous thrombosis
Target vein under 2 mm or over 15 mm in diameter
Subcutaneous anastomosis of the target vein, or aneurysmal dilatation at the junction
Extreme tortuosity unsuited to radiofrequency ablation
Known lidocaine allergy
Severe hepatic or renal dysfunction
Poorly controlled hypertension or diabetes
Non-primary varicose veins — post-thrombotic syndrome, iliac vein compression, Klippel–Trénaunay syndrome, arteriovenous fistula
Pacemakers and other active implants, without prior specialist consultation

Potential complications

Peripheral nerve injury
Haematoma
Deep vein thrombosis and pulmonary embolism
Phlebitis
Infection
Skin burns or discolouration
Vessel perforation
Recurrence

Post-procedure

Early and frequent ambulation; avoid heavy lifting for several days
Compression maintained for at least one week
Duplex assessment within 72 hours to exclude thrombus extension into the deep system

Reporting. Serious incidents involving the device should be reported to the manufacturer and to the South African Health Products Regulatory Authority. Kirsion Medical will assist with vigilance reporting on request.

Information on this page is intended for healthcare professionals. Full indications, contraindications, warnings and potential complications are set out in the manufacturer's Instructions for Use, which take precedence over any summary presented here.

Regulatory conformity

Mechanism of action

Stated clinical benefit

Published literature

Intended use

Certificate of record

Contraindications and complications

Contraindications

Potential complications

Post-procedure

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