520340: Coloplast Saffron Fixation Tool for Pelvic Floor Reconstruction

In-Date » Coloplast » Pelvic Health

Coloplast Saffron Fixation System for Transvaginal Surgical Pelvic Floor Reconstruction

The Saffron Fixation System is indicated for attaching sutures to ligaments of the pelvic floor. It can be used with patients who are good surgical candidates for transvaginal surgical pelvic floor reconstruction. Saffron pairs consistent, reliable control and anchor deployment with ease of navigation, all while allowing surgeons to use their choice of suture and needles for POP repair. The design is intuitive, and easy to use, and surgeons report high satisfaction with the Saffron system.

The two-piece system consists of one Saffron tool and biocompatible Saffron anchors (sold separately in boxes of 12). The Saffron tool is intended for multiple uses in a single surgical procedure. The anchors are intended to be permanently implanted and are for single-use only.

Product Code: 520340

• Use with your choice of commercially available sutures
• Accommodates most off-the-shelf sutures up to size 0 in any material or length (excluding barbed sutures)
• A wide array of needles can be used for the repair

Sterilization

• Device Packaged as Sterile: Yes
• Requires Sterilization Prior to Use: No 
• Single-Use
• Disposable

Additional Details

• Company Name: Coloplast A/S
• FDA Product Code: PBQ
• FDA Product Code Name: Fixation, non-absorbable or absorbable, for pelvic use
• GMDN Term Code: 45612
• GMDN Term Name: Soft-tissue/mesh anchor, non-bioabsorbable
• GMDN Term Definition: A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

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.