Caldera Medical receives FDA approval for sacrocolpopexy mesh

26 June 2013 (Last Updated June 26th, 2013 18:30)

Caldera Medical, US-based developer of surgical implants has received approval from the US Food and Drug Administration (FDA) for Vertessa Lite, a polypropylene mesh for use in abdominal sacrocolpopexy procedures.

Caldera Medical, US-based developer of surgical implants has received approval from the US Food and Drug Administration (FDA) for Vertessa Lite, a polypropylene mesh for use in abdominal sacrocolpopexy procedures.

The company has also announced the launch of VertessaLite, which further broadens its product range.

Vertessa Lite is a large pore, monofilament, polypropylene mesh that is blue in color for visibility and handling.

Caldera Medical noted that although the Vertessa Lite is a thin mesh designed for sacrocolpopexy procedures, it is 63% stronger than the market leading mesh for sacrocolpopexy.

Vertessa Lite weighs 23.8g/m² with an average pore size of 1,300 microns, and is available in three sizes with lengths up to 30cm and a Y-Mesh design.

Large pore and lightweight characteristics of mesh are recognised to improve host tissue acceptance, while strength is important for the durability of the repair.

Abdominal sacrocolpopexy procedures are expected to grow approximately 15% in 2013 as most of the patients are shifting from transvaginal prolapse repair procedures.

Sacrocolpopexy procedures treat vaginal vault prolapse, a type of pelvic organ prolapse (POP).

POP affects nearly 50% of all women who give birth vaginally, and a woman's lifetime probability of undergoing a surgical treatment for POP is approximately 11%.

According to Caldera Medical, as patients with POP are often diagnosed with stress urinary incontinence (SUI), the company's SUI implant Desara can be used together in the same surgical procedure as Vertessa Lite.

Desara is a sling system that provides surgeons with their choice of multiple surgical approaches by utilising reusable instrumentation.

Las Palmas Medical Center minimally invasive gynecology surgeon Dr. Richard Farnam said that Vertessa Lite represents a significant advance in sacrocolpopexy mesh.

"Vertessa Lite is lightweight, easy to handle, conforms well to the patient's anatomy and has greater tensile strength than other lightweight meshes, which is important to me," Farnam added.

Caldera Medical develops and markets surgical implants for the treatment of SUI, POP across the gynecology, urology and urogynecology specialties.