Medtronic PLC (NYSE:MDT) released on Thursday results from the Enable Hernia Repair clinical study evaluating the performance of the Hugo robotic-assisted surgery (RAS) system in inguinal and ventral hernia repair procedures.
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Enable Hernia Repair is a prospective, multi-center, single-arm pivotal study that included 193 patients undergoing either inguinal or ventral robotic hernia repair with the Medtronic Hugo RAS system.
Enable Hernia Repair is the first-ever Investigational Device Exemption (IDE) clinical study completed for robotic-assisted hernia surgery in the U.S.
Primary safety and effectiveness endpoints were met. Key findings included that the surgical success rate was 100%, surpassing the pre-specified performance goal of 85%.
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The study met the primary safety endpoint for both cohorts, which were analyzed independently.
Among 92 inguinal patients available for analysis, the surgical site event (SSE) rate was 0.0%, which is significantly lower than and meets the pre-determined performance goal of 30% (p <0.0001).
Among 94 Ventral patients available for analysis, the SSE rate was 2.1%, which is significantly lower than and meets the pre-determined performance goal of 30% (p <0.0001); two SSEs were recorded and resolved without complication.
In the Enable Hernia Repair clinical study, the mean length of hospital stay was 4.7 hours for inguinal patients and 6.7 hours for ventral.
Every year, nearly 1.5 million hernia repair surgeries are performed in the U.S., making hernia repair one of the most common surgeries for adult men and women.
Hernia repair addresses conditions where part of the intestine bulges through weakened abdominal muscles. Left untreated, hernias can lead to pain, digestive troubles, swelling or infection.
In the U.S., the company’s submission for a urology indication is under review by the Food and Drug Administration, with a U.S. urology indication expected later in the company’s current fiscal year, followed by planned indication expansions into hernia repair and gynecology.
The Medtronic Hugo RAS system is commercially available in certain regions. In the U.S., the Hugo RAS system is an investigational device.
MDT Price Action: Medtronic stock is up 0.39% at $93.21 at publication on Friday.
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