Device Description

The Mendit device is a sterile, single-use, disposable system intended for the surgical repair of pelvic organ prolapse (POP). It functions by anchoring sutures to pelvic-floor ligaments (e.g., the sacrospinous ligament) to provide apical suspension support.

Intended Purpose 

The Mendit system is indicated for use in adult female patients with apical pelvic organ prolapse (uterine or vaginal/apical compartment), with or without associated anterior and/or posterior compartment defects. 

Use is restricted to qualified surgeons trained in pelvic floor procedures. 

User Information

The device is intended for trans-vaginal placement. User is restricted to trained surgeons in accordance with the Instructions For Use (IFU)

Safety Information 

• The device is sterile and intended for single use only. Do not re-sterilize or reuse.
• The implant contains nitinol (nickel–titanium alloy). Patients with known nickel hypersensitivity should inform their physician prior to implantation.
• The implant is MR Conditional. Patients should inform healthcare providers of the presence of the implant prior to undergoing MRI. Refer to the Instructions for Use for MRI conditions and limitations.
• In case of unusual symptoms or suspected complications, patients should contact their healthcare provider without delay.

For complete instructions, warnings, precautions, and MRI conditions, refer to the Instructions for Use supplied with the product.

Adverse Event Reporting 

Report any adverse events related to the Mendit device to:

Escala Medical Ltd.
Email: customerservice@escalamedical.com

Serious incidents occurring within the European Union should also be reported without delay to the EU Authorized Representative listed above and to the competent authority of the Member State in which the user and/or patient is established.

Regulatory Status 

The regulatory status of the Mendit System varies by region.
CE certification status will be updated following completion of conformity assessment under Regulation (EU) 2017/745.

Summary of Safety and Clinical Performance (SSCP)

Following CE certification, the Summary of Safety and Clinical Performance (SSCP) will be made publicly available in accordance with Article 32 of Regulation (EU) 2017/745

Manufacturer Information

Escala Medical Ltd.
17th Tchelet St., Business Park Misgav
2017400 Israel
Email: customerservice@escalamedical.com
Phone: +972-72-2607000
www.escalamedical.com

European Authorized Representative

MedNet EC-REP III GmbH
Borkstraße 10
48163 Münster
Germany
SRN: DE-AR-000011191
www.mednet-eurep.com