Israeli Startup Develops a Minimally Invasive Approach for Uterine Prolapse Repair Procedures
Pelvic organ prolapse occurs when the organs in the pelvic region of the
woman’s body sag or drop—a condition that affects nearly half of women
during their lifetime. Current available treatments include mesh surgery or
hysterectomy, both of which are invasive, complex, and with known side
effects, to the point that the FDA has removed transvaginal mesh from the
market. Israeli company FEMSelect (FKA POP Medical Solutions) therefore
developed their patented product, EnPlace, a minimally invasive, mesh-free
approach to prolapse repair. The EnPlace system is comprised of a suture
and nitinol (a metal alloy with elastic properties) anchor which attaches to
the cervix for pelvic floor stabilization system in a 30-minute procedure
using a unique and innovative delivery system.
EnPlace has undergone preclinical studies in both animals and human
cadavers, an early clinical study with successful results at 4 years as well
as a larger Post-Marketing Study (PMS). The PMS for treatment of prolapse
shows a durable repair in 50 women at 1-year after the procedure and will
continue to follow the women for an additional 4 years. EnPlace has
received FDA clearance and CE Mark and is now available commercially in
the US and Israel.
woman’s body sag or drop—a condition that affects nearly half of women
during their lifetime. Current available treatments include mesh surgery or
hysterectomy, both of which are invasive, complex, and with known side
effects, to the point that the FDA has removed transvaginal mesh from the
market. Israeli company FEMSelect (FKA POP Medical Solutions) therefore
developed their patented product, EnPlace, a minimally invasive, mesh-free
approach to prolapse repair. The EnPlace system is comprised of a suture
and nitinol (a metal alloy with elastic properties) anchor which attaches to
the cervix for pelvic floor stabilization system in a 30-minute procedure
using a unique and innovative delivery system.
EnPlace has undergone preclinical studies in both animals and human
cadavers, an early clinical study with successful results at 4 years as well
as a larger Post-Marketing Study (PMS). The PMS for treatment of prolapse
shows a durable repair in 50 women at 1-year after the procedure and will
continue to follow the women for an additional 4 years. EnPlace has
received FDA clearance and CE Mark and is now available commercially in
the US and Israel.