Caldera Medical, Inc. announced that it has received FDA approval and CE Mark certification for the Ascend Pelvic Floor Repair System with Apical Support. Ascend provides a novel treatment for female pelvic organ prolapse. It is designed to treat pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).
Ascend based on CentraSoft mesh technology provides apical support from the anterior compartment through a unique implant geometry. It reduces invasiveness and enhances patient outcomes. CentraSoft mesh technology provides a thin, lightweight central mesh designed to conform to the patient’s anatomy with stronger lateral arms for support. Ascend treats patients with anterior and apical defects with one surgical implant, reducing the potential for complications. Bryon L. Merade, CEO, commented, We are very excited about Ascend’s cutting edge technology and the option it provides surgeons to treat their patients with minimally invasive techniques utilizing the fewest number of implants possible. Ascend underscores our commitment to improving women’s health.
Tomas Antonini, M.D. of Round Rock, TX, one of the nation’s leading urogynecologists, said, Ascend fulfils a need surgeons have had for years for an implant that can treat both anterior compartment and apical prolapse at the same time and in the same procedure. The ability to treat these two defects with a single implant will address a common cause of failures seen in these types of repairs. Caldera has once again brought a unique technology to market in an effort to improve the treatment of pelvic organ prolapse and stress urinary incontinence.