Altis Delivers

Time After Time

Most rigorously studied single incision sling, now supported by even more clinical research.

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Quick Links: Study design | Patient demographics | Results | Proven safety | Proven effectiveness
Proven satisfaction | The power of Altis | Subscribe to emails | Important safety information

Patient after patient. Visit after visit. Three years of convincing data. Put your trust in Altis, the minimally invasive sling that can help your patients move beyond the daily limits of short-term solutions to experience long-term gains. The latest evidence shows at 36 months, Altis continues to perform similarly to full length retropubic and transobturator slings in treating stress urinary incontinence (SUI). Altis demonstrates similar performance in safety and efficacy1–delivering the proof you want and the solution your patients need.

Time after time

Download the clinical summary

Altis 522 Post-Market Surveillance Study Design

Prospective, multi-center,
nonrandomized study

Women underwent
sling procedures

Physicians

Different sites (US & Canada)





Slings Tested

Single Incision Sling:
Altis
 

Comparator:
Full length retropubic
& transobturator slings





Timeframe Observed

Altis 522 Study Patient Demographics2

Convincing Results.

Time After Time

Altis performs similarly to full length retropubic and transobturator slings in:

Safety

Effectiveness

Patient Satisfaction

Proven Safety.

Time After Time

The safety of your patients is your top priority and Altis consistently delivers. Designed to make procedures straight-forward, accurate and repeatable3,1, Altis demonstrated similar safety results to full length slings in the 36 month study.

Altis clinical performance data should provide the reassurance needed for your patients.

 

Altis vs Comparator

Device and/or procedure related serious adverse events (SAE)

Data for the treated population are presented as the number of subjects (%)

Compared to full length retropubic and transobturator slings, Altis:

  • Had similarly low rates of device and/or procedure related serious adverse events
  • Zero cases of mesh exposure, extrusion or erosion

Proven Effectiveness.

Time After Time

Altis provides the certainty you need with outcomes you expect. Data through 36 months reinforces reliability over time with Altis reporting similar efficacy as full length retropubic and transobturator slings. This evidence is more proof that Altis allows your patients to move beyond the limits of short-term solutions to experience long-term success.

87.1% Altis®

CST demonstrated Altis was similar to retropubic and transobturator slings (p<0.001)

Altis performed similarly to the Comparator arm at every study visit and rates of negative CST remained above 80% for both groups.

 

The rate of Altis patients with dry pad weight was similar to patients in the Comparator arm through 36 months.

Proven Satisfaction.

Time After Time

Altis is changing womens’ lives. Day in and day out. According to the latest research, Altis and full length sling patients had a high degree of satisfaction with their surgery. With an SUI treatment that’s more efficient and less invasive4, your patients need to know about the Altis alternative—and deserve a choice in their care.

checkmark-icon Patients had a high degree of satisfaction with their surgery5
checkmark-icon Pain decreased similarly5

  • De novo dyspareunia related to procedure
    and/or device
  • Pelvic/urogenital pain (groin)
checkmark-icon Improvement in quality of life and return to normal increased similarly5
checkmark-icon No difference in satisfaction in the amount of time to return to daily activities and work5

The Power of Altis.

Time After Time

LESS INVASIVE
One incision. Less tissue trauma. Speed up procedure time and deliver a better patient experience.3,4

STABLE SUPPORT
Patented, flexible, lightweight mesh is the thinnest available, allowing support of the urethra.3

REPRODUCIBLE INSERTION
Patented helical introducer makes the surgical procedure straightforward, accurate and reproducible.3

PRECISE TENSIONING
Place the device, then control the adjustable tensioning.3

RIGOROUSLY STUDIED
50+ publications. 3,000+ patients studied. The only sling
with a pre-market IDE and completed 522 study.

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PM-27972

Altis® Single Incision Sling System Brief Statement

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
It is the responsibility of the physician to advise the prospective patients prior to surgery, of the contraindications associated with the use of this product. The Altis Single Incision Sling System is contraindicated for use in patients with one or more of the following conditions:

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

Warnings
It is the responsibility of the physician to advise prospective patients prior to surgery, of the warnings associated with the use of this product and the associated surgical risks.

The Altis Single Incision Sling System should only be used by physicians experienced in the surgical procedures involving transvaginal placement of non-absorbable, synthetic mesh slings. A thorough assessment of each patient should be made to determine the suitability of a synthetic mesh sling procedure.

The patient should be counseled that alternative incontinence treatments may be appropriate prior to surgical intervention.

Obtain patient consent prior to surgery and ensure that the patient understands the postoperative risks and potential complications of transvaginal mesh sling surgery and that the Altis implant is permanent.

Serious mesh associated complications may result in one or more revision surgeries which may lead to partial or complete removal of the mesh. Complete removal of the mesh may not always be possible or advisable, and removal may not fully correct these complications. There may be unresolved pain with or without mesh explant. De novo complications and recurrence or worsening of SUI can occur.

Patient-Related Warnings
As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, mesh sling exposure or other complications and adverse events.

The risks and benefits of using Altis should be considered in patients with:

  • Age-related underlying conditions
  • Autoimmune disease
  • Coagulation disorder
  • Connective tissue disorder
  • Debilitated or immunocompromised state
  • Diabetes
  • Pelvic radiation therapy or chemotherapy
  • Physical characteristics (e.g., body mass index)
  • Renal insufficiency
  • Smoking-related underlying conditions
  • Urinary tract anomalies

Future pregnancy could negate the benefits of this surgical procedure. Patients should report bleeding, pain, abnormal vaginal discharge or signs of infection at any time.

Potential Complications
Adverse events are known to occur with transvaginal synthetic sling procedures and implants and may include:

Abnormal vaginal discharge, abscess, adhesion, allergic reaction, hypersensitivity, or maladaptive immune response, bladder storage symptoms (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), bleeding/hemorrhage or hematoma, delayed/impaired/abnormal wound healing, dyspareunia, exposure, extrusion, or erosion of mesh sling or suture into the vagina or other structures and organs, fistula formation, granuloma/scar tissue formation, hispareunia (male partner pain with intercourse), infection, inflammation/irritation, necrosis, neuromuscular disorder, pain, palpable mesh (patient and/or partner), pelvic/urogenital pain, perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel, vagina), scarring, seroma, sexual dysfunction, sling migration, tensioning suture exposure, ureteral obstruction, urinary tract infection, vaginal tightening/shortening, voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream) or wound dehiscence.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
PM-03363 04/2024

References

  1. Tu LM, Gheiler E, Hanson CE, Jalkut M, McCrery R, Parekh M, Parva M, Erickson T. Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes. Neurourol Urodyn. 2023 Aug 9. doi: 10.1002/nau.25256. Epub ahead of print. PMID: 37555436.
  2. Erickson T, Roovers JP, Gheiler E, Parekh M, Parva MM, Hanson C, McCrery R, Tu LM. A multi-center prospective study evaluating efficacy and safety of a single-incision sling procedure for stress urinary incontinence. J Minim Invasive Gynecol. 2020 Apr 19. pii: S1553-4650(20)30189-8.​
  3. Data on file
  4. Mostafa A, Lim CP, Hopper L, Madhurvata P, Abdel-Fattah M. Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Euro Urology. 2014;65(2):402-427. doi:10.1016/j.eururo.2013.08.032.
  5. Hanson, C, Erickson, T., McCrery R. Patient satisfaction and quality of life in a multicenter prospective study of single incision mini-sling (Altis®) in the management of female stress urinary incontinence. Journal of Urology. 2023 Apr 29. e516 Vol 209, No. 4S, Supplement.

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Minneapolis MN 55411 USA
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