Caldera Medical, Inc. (Agoura Hills, CA) has received FDA clearance for the Ascend Pelvic Floor Repair System with Apical Support for female pelvic organ prolapse treatment.
Caldera Medical, Inc. (Agoura Hills, CA) has received FDA clearance for the Ascend Pelvic Floor Repair System with Apical Support for female pelvic organ prolapse treatment.
The Ascend system provides apical support from the anterior compartment through implant geometry utilizing CentraSoft mesh technology and a patented surgical method that is designed to both reduce invasiveness and enhance 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, according to Caldera.
For patients with both anterior and apical defects, the product offers the ability to treat both defects with one surgical implant, reducing the potential for complications and the cost to the health care system, the company said in a statement.
"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," said Tomas Antonini, MD, a urogynecologist in Round Rock, TX. "The ability to treat these two defects with a single implant will address a common cause of failures seen in these types of repairs."
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