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Jun 03, 2023

Caldera Medical’s Desara TVez Transvaginal Sling System, US

Caldera Medical’s Desara® TVez sling allows effective and safe surgical procedures in women with stress urinary incontinence. Transvaginal sling system Caldera Medical Female stress urinary

Caldera Medical’s Desara® TVez sling allows effective and safe surgical procedures in women with stress urinary incontinence.

Transvaginal sling system

Caldera Medical

Female stress urinary incontinence

Approved in the US

Desara® TVez is a transvaginal sling system for the treatment of female stress urinary incontinence (SUI). The device improves physicians’ flexibility as well as the usability of their tools and implants during surgical procedures.

The Desara® system is an expansion of the Desara® family of products developed by US-based medical device company Caldera Medical to treat female SUI and other pelvic health disorders.

The device received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for urinary incontinence in women in December 2021.

Desara® TVez sling system is comprised of a mesh implant, with enclosed dilator tips to enable smoother tissue passage, as well as EZ Tab for simplified removal and disposable introducer.

Desara® TVez introducer (trocar) is available in two diameters, 2.7mm and 3mm, which are used to insert the implant into the body. The 85° tighter trocar curve closely contours the pubic bone of the patient without touching any other critical anatomy.

The enclosed dilator tips in the system lower tissue drag, which minimises insertion force, while the extension of the dilator tube enables easy removal of the trocar.

The trocar-assisted sling suspension system is designed for the placement of mesh in females, utilising a transvaginal approach, for the treatment of genuine SUI, mixed incontinence caused by urethral hypermobility, or intrinsic sphincter deficiency. The device enhances control, simplifies the surgical procedure for physicians and ensures patient safety.

The Desara® mesh is made of type I large pore monofilament polypropylene with a large pore size of about 1000µ. It encourages tissue in-growth and enables macrophage movement. It is designed to lay flat when tensioned without tearing or curling, providing steady and controlled support. The blue colour of the mesh enables better visualisation for physicians. The mesh supports the pelvic region of women for the treatment of pelvic disorders.

The disposable placement aids, such as sleeves and dilator tubes, on the mesh assist physicians in the placement of the system and are removed after the procedure.

Caldera’s Desara® TVez implants are intended to be used with the Caldera Medical introducer, which comes with the implant. The robust reusable introducers are precisely constructed from surgical-grade stainless steel to ensure secure and reliable needle passage.

Caldera Medical is a medical device company based in the US. It is dedicated to women’s health and develops, manufactures and markets surgical devices for the treatment of pelvic health disorders, including SUI, pelvic organ prolapse, polyps and fibroids.

The company’s product portfolio includes the Desara® family for the treatment of SUI, the Vertessa® family for the treatment of pelvic organ prolapse, and the Benesta™ system for the treatment of uterine polyps.

The Desara® product offerings allow surgeons to choose between transvaginal, suprapubic, transobturator outside-in and inside-out, and single-incision slings.

The firm nurtures close connections with surgeons to improve its products through effective engagement and collaboration.

Caldera has partnered with the pelvic awareness project (PAP) to reach one million women in underserved populations by 2025 by providing treatment and education globally. PAP focuses on informing and educating women about pelvic health concerns that affect millions of women.

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