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93-4400: Coloplast Aris Trans-Obturator Surgical Sling Kit
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| Price: | $999.00 per kit |
|---|---|
| In Stock: | 0 kits |
| Expiration: | In-Date |
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Additional Details
Coloplast Aris Trans-Obturator Surgical Sling Kit
Product Code: 93-4400
Aris is a permanent, synthetic, midurethral support sling that has been developed specifically for implantation using the transobturator technique. Aris is a macroporous, knitted, monofilament polypropylene sling with low elasticity .
Low Elasticity and Less Material
The Aris sling has low elasticity at 7.5%, similar to collagen fibers. This allows the Aris sling an accurate tension-free adjustment. Aris has a thickness of 0.3mm for less implanted material and providing urethral support. (cf. 1)
No Sheath or Tensioning Suture
The Aris sling allows for simple and quick insertion, with no sheath or tensioning suture. No sheath reduces the complexity of the procedure and surgery time.
No Barbed or Tanged Edges
The Aris sling has unique, heat sealed edges without barbs facilitate easy passage during implantation, which helps to minimize trauma to the surrounding tissue.
Choice of Introducers
The Aris Sling System is supplied with the Aris sling and a set of 3 introducers- helical and a flat curved. The Aris introducers are ergo-dynamic allowing for easy grasp and passage thru the obturator space. The low 3.1mm profiles of the introducers are designed to minimize tissue damage during insertion and to minimize the extent of a blind passage.
AccessGUDID Info
- FDA Product Code: OTN
- FDA Product Code Name: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
- GMDN Term Code: 57874
- GMDN Term Name: Suturing unit, single-use
- GMDN Term Description: A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
- GMDN Term Code: 47986
- GMDN Term Name: Female stress urinary incontinence surgical mesh-sling, synthetic polymer
- GMDN Term Description: A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.
Manufacturer
Coloplast is a global medical device company focused on products that support intimate healthcare needs, with key specialties in urology, continence care, and wound and skin care. In the urology and surgical space, Coloplast offers a wide range of solutions including male and female continence products, penile implants, testicular implants, and surgical mesh for pelvic organ prolapse and stress urinary incontinence. Their Interventional Urology portfolio includes devices for stone management, BPH treatment, and access products used in urological procedures. Known for patient-centered innovation and discreet, effective solutions, Coloplast works closely with clinicians to improve quality of life for individuals with chronic or sensitive health conditions.
