TransEnterix announced expanded FDA clearance for the Senhance Surgical System, which last fall became the first new abdominal surgical robotics device to enter the U.S. market in nearly two decades. The Senhance now has the necessary federal stamp of approval for laparoscopic inguinal hernia and laparoscopic cholecystectomy surgery.
The system was previously cleared for laparoscopic colorectal and gynecologic surgeries. The company did the math and notes that the new clearance pushes the “Senhance System’s total addressable annual procedures in the U.S.” to a number in excess of 3 million.
“This indication expansion immediately doubles the addressable market for Senhance in the U.S. and validates our regulatory strategy to successfully add to our indications for use,” Todd M. Pope, president and CEO of TransEnterix, said in a statement. “These expanded procedures are commonly performed at over 95 percent of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice.”
The expanded clearance comes as TransEnterix is celebrating a strong first quarter in 2018, bolstered by Senhance sales numbers that exceeded most observers’ expectations. Two days after the FDA clearance was announced, the company celebrated the acquisition of the Senhance by LSU Health, which installed the system at University Medical Center New Orleans.
The Senhance provides a future-facing way to serve patient needs, according to Lisa M. Peacock, MD, chairperson of the department of obstetrics and gynecology and section head and program director of female pelvic medicine and reconstructive surgery at LSU Health New Orleans.
“Patients are seeking minimally invasive options that utilize the most advanced technology to treat gynecologic conditions,” Peacock said in a statement. ”As an academic medical center, we believe this new robotic surgical platform will play an important role in our continued leadership in surgical teaching, research, and providing excellent patient care.”
Before the end of the year, the company expects to seek federal approval for several enhancements to the Senhance, including 3 millimeter instruments, 5 millimeter articulating instruments, and ultrasonic energy instruments.
