1. Product characteristics
2. Sterilisation
3. Technical parameters

Dallop NM ULTRALIGHT

1. Product Description
Non-resorbable, ultra-lightweight surgical urological tapes are knitted from monofilament polypropylene yarn, in transparent and blue. A blue line along the length of the tape facilitates visibility in the surgical field and allows for its identification if tension adjustment is necessary. The tapes are equipped with blue handles made of monofilament polypropylene yarn, secured with a heat-shrinkable sleeve, facilitating attachment to the applicator.

Intended use

Dallop® NM ULTRALIGHT urological tape is recommended for use during surgical procedures to treat stress urinary incontinence (SUI). Surgical treatment of urinary incontinence involves suspending the urethra with a tension-free urological tape. The device is intended for implantation using the following methods: Tension-Free Vaginal Tape (TVT), Trans Obturator Tape (TOT), or Tension-Free Vaginal Tape-Obturator (TVT-O). The physician selects the optimal method. Specially designed applicators, depending on the chosen method, allow for safe insertion of the tape into the patient’s body. The products are intended for use by a professional user – a specialist physician – in patients scheduled for surgical procedures for the treatment of Stress Urinary Incontinence.

Dallop® NM ULTRALIGHT ultralight tapes are characterized by a significant reduction in the amount of implanted material (several times lower surface mass compared to Dallop® NM) and reduced trauma, while providing appropriate mechanical properties to support damaged connective tissue structures while ensuring adequate product strength. Additionally, the product is characterized by:

• Biostability, which prevents it from losing its physical properties during prolonged contact with tissues and body fluids,
• a porous structure that minimizes the risk of bacterial infection,
• an optimally designed three-dimensional structure, where the pore size allows for rapid overgrowth with connective tissue

2.Product Sterility Information
Dallop® NM ULTRALIGHT urological tapes are offered for sale as sterilized using ethylene oxide (EO) sterilization. The product cannot be resterilized. The product maintains its sterility within the specified expiration date, only in the original packaging, under appropriate storage conditions. If the outer or inner packaging is damaged, the medical device should be considered non-sterile and must not be used.

3.Technical Parameters

Low linear mass
The low linear mass ensures patient comfort. Trends in the design of innovative medical implants are aimed at using the minimum amount of foreign material possible.

Two tape sizes (lengths) available: 30 cm and 45 cm

Optimal Width
The appropriately selected width allows for a low linear mass, which prevents urethral erosion.

High porosity and varied pore sizes
The porosity of the tape and the varied pore sizes of the average size ensure proper healing of the tape while simultaneously improving urethral function. Low elasticity allows for better tape conformability. This weave also minimizes the typical several percent shrinkage of polypropylene over time. High porosity means less alloplastic material is implanted.

Adequate yarn
The tape is made of 0.08 mm thick monofilament polypropylene yarn.

The yarn thickness, adapted to the large pore size, provides the required strength. This parameter provides a relatively large unit contact surface with soft tissue, thus preventing tape ingrowth, cutting, and erosion of the urethra and bladder.