Bariatric sling Altis®

Overview
A fully adjustable, minimally invasive surgical solution specifically designed to treat female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Key clinical points and outcomes
Altis® is the most rigorously studied single incision sling with multiple clinical studies demonstrating noninferiority to full‑length midurethral slings.

Selected clinical study outcomes (Patient Global Impression of Improvement - “very much” or “much” improved)
Abdel‑Fattah et al., N Engl J Med 2022 — 36 months; n=596: Full‑length TO/RP slings: 66.8%
Single Incision Sling / Altis®: 72.0%

Matthews et al., AJOG 2024 — 12 months; n=255: Full‑length RP sling: 67%
Single Incision Sling / Altis®: 71%

Erickson et al., Urogynecology 2024 — 36 months; n=355: Full‑length TO/RP sling: 90.1%
Single Incision Sling / Altis®: 92.9%

Safety / outcome highlights

• <3.3% rates of mesh exposure, extrusion or erosion reported in referenced studies
• Zero incidences of bladder trocar or urethral injuries reported in referenced studies
• Ease of use rated high by surgeons experienced with retropubic slings

Patient experience benefits

• Reduced procedure and recovery time
• Less post‑operative pain (reported up to 14 days)
• Lower rates of post‑operative voiding dysfunction
• Quicker return to normal activities

Design and components

• Mesh engineered for support and stability — designed to emulate the pubourethral ligament; maintains integrity and pore size under tension; described as the lightest and thinnest SUI mesh available
• Introducers developed for safety and repeatability — allow passage into the obturator membranes while avoiding critical structures and minimizing post‑operative risks
• Anchors engineered for precise tensioning and secure hold — dynamic anchor enables adjustment after introducer removal; anchors are placed in the obturator membrane to secure the sling immediately upon placement

Indications
The Altis® Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Contraindications

• Pregnancy or desire for future pregnancy
• Potential for further growth (e.g., adolescents)
• Known active urinary tract infection and/or infection in the operative field
• Ongoing anticoagulant therapy
• Abnormal urethra (e.g., fistula, diverticulum)
• Any condition, including known or suspected pelvic pathology, that could compromise the implant or its placement
• Documented hypersensitivity or allergic reaction to polypropylene or polyurethane

Warnings and precautions
The device should be used only by physicians experienced in transvaginal placement of non‑absorbable synthetic mesh slings. Perform a thorough patient assessment to determine suitability. Counsel patients on alternative treatments and postoperative risks. Serious mesh‑associated complications may require revision surgeries and partial or complete mesh removal; complete removal may not always be possible or fully corrective.

Patient-related warnings
Patients with underlying conditions (advanced age, autoimmune disease, coagulation disorders, connective tissue disorders, immunocompromised state, diabetes, prior pelvic radiation or chemotherapy, renal insufficiency, smoking, urinary tract anomalies, significant BMI or other physical characteristics) may have increased risk of bleeding, impaired healing, mesh exposure or other complications. Future pregnancy may negate the benefits of the procedure. Patients should report bleeding, pain, abnormal vaginal discharge or signs of infection promptly.

Potential complications (non-exhaustive)

• Abnormal vaginal discharge, abscess, adhesion, allergic reaction or maladaptive immune response
• Bladder storage symptoms (frequency, urgency, nocturia, overactive bladder)
• Bleeding/hematoma, delayed or impaired wound healing
• Dyspareunia, exposure/extrusion/erosion of mesh or suture into the vagina or other organs, fistula, granuloma/scar tissue
• Infection, inflammation, necrosis, neuromuscular disorder, chronic pain
• Perforation or injury to adjacent muscles, nerves, vessels, or organs (bone, bladder, urethra, ureters, bowel, vagina)
• Sling migration, tensioning suture exposure, ureteral obstruction, urinary tract infection, voiding symptoms (dysuria, retention, incomplete emptying, obstruction)

Product resources (available formats vary by product page)

• Clinician videos and animations demonstrating the dynamic anchor, introducer use, in‑office procedure demonstrations and sling tensioning techniques
• Product brochure and procedural steps document (PDF)

Features / technical specifications

• Brand: Coloplast
• Model: Altis®
• Primary indication: Treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or ISD
• Sling length option shown on page: 7.75 cm
• Purchase UOM (unit of measure): EA
• Qty per UOM (example): 1
• Introducers: Helical type introducers included (example quantity on page: 2 EA)
• Item number (reference on page): 519650 (associated with the 7.75 cm sling and introducers)
• Mesh: Light‑weight, thin SUI mesh designed to emulate the pubourethral ligament and maintain pore size under tension
• Anchors: Dynamic anchor enabling post‑placement tension adjustment; anchor placed in obturator membrane
• Clinically reported metrics: study outcomes and comparative success rates as listed above; reported <3.3% mesh exposure/extrusion/erosion in referenced studies