Rachel Klemovitch, Assistant Editor02.26.24
The U.S. Food and Drug Administration has granted Virtual Incision marketing authorization for its MIRA Surgical System. This is the first miniaturized robotic-assisted surgery (miniRAS) device for adults undergoing colectomy procedures.
The device was submitted through the FDA’s De Novo Classification process and authorization was granted based on findings from Virtual Incision’s U.S. IDE clinical study.
The introduction of robotic-assisted surgery offers surgeons more precision and control than conventional techniques, expanding the use and effectiveness of minimally invasive surgery (MIS) for complex procedures. MIS involves smaller incisions and has been shown to reduce complications, shorten recovery time, and decrease pain.1
Roughly 90% of US operating rooms are still without access to MIS technology,2 mostly due to a lack of operating space, complex logistics, specialty trained staff, and the cost of the equipment.
“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” company president and CEO, John Murphy told the press. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence. Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”
The tray-to-table design of MIRA could offer healthcare facilities the advantages of robotic surgery without requiring operating rooms to be reorganized around the device. MIRA is compact, with the framework weighing approximately two pounds. It is portable and designed to minimize setup time.
“Colectomy is one of the most complex multi-quadrant abdominal procedures with nearly 50 percent still being performed as open surgery.3 Data from our IDE clinical study demonstrated that MIRA can successfully be used to mobilize the colon in a minimally invasive way,4” said chief medical officer of Virtual Incision, Piet Hinoul. “Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications. We’re thankful to the investigators and patients who participated in our IDE clinical study that propelled us to marketing authorization.”
Virtual Incision will begin commercialization through its First Access Program in selected centers across the US. The company plans to expand production of MIRA to additional sites over time.
MIRA expects to expand its roadmap to include gynecology, urology, general surgery, and other soft tissue and solid organ surgery. Gynecology procedures studies of MIRA are planned for 2024. A new iteration of the technology for general surgery is currently in design and is planned for a first-in-human study outside the US later this year.
References:
1. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006 Aug;93(8):921-8.
2. Hazan, A., Perse, J., Coover, P. June 2022. State of the Robotics Surgery Market. Goldman Sachs.
3. Sheetz KH, Norton EC, Dimick JB, Regenbogen SE. Perioperative Outcomes and Trends in the Use of Robotic Colectomy for Medicare Beneficiaries From 2010 Through 2016. JAMA Surg. 2020 Jan 1;155(1):41-49.
4. Virtual Incision data on file
The device was submitted through the FDA’s De Novo Classification process and authorization was granted based on findings from Virtual Incision’s U.S. IDE clinical study.
The introduction of robotic-assisted surgery offers surgeons more precision and control than conventional techniques, expanding the use and effectiveness of minimally invasive surgery (MIS) for complex procedures. MIS involves smaller incisions and has been shown to reduce complications, shorten recovery time, and decrease pain.1
Roughly 90% of US operating rooms are still without access to MIS technology,2 mostly due to a lack of operating space, complex logistics, specialty trained staff, and the cost of the equipment.
“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” company president and CEO, John Murphy told the press. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence. Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”
The tray-to-table design of MIRA could offer healthcare facilities the advantages of robotic surgery without requiring operating rooms to be reorganized around the device. MIRA is compact, with the framework weighing approximately two pounds. It is portable and designed to minimize setup time.
“Colectomy is one of the most complex multi-quadrant abdominal procedures with nearly 50 percent still being performed as open surgery.3 Data from our IDE clinical study demonstrated that MIRA can successfully be used to mobilize the colon in a minimally invasive way,4” said chief medical officer of Virtual Incision, Piet Hinoul. “Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications. We’re thankful to the investigators and patients who participated in our IDE clinical study that propelled us to marketing authorization.”
Virtual Incision will begin commercialization through its First Access Program in selected centers across the US. The company plans to expand production of MIRA to additional sites over time.
MIRA expects to expand its roadmap to include gynecology, urology, general surgery, and other soft tissue and solid organ surgery. Gynecology procedures studies of MIRA are planned for 2024. A new iteration of the technology for general surgery is currently in design and is planned for a first-in-human study outside the US later this year.
References:
1. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006 Aug;93(8):921-8.
2. Hazan, A., Perse, J., Coover, P. June 2022. State of the Robotics Surgery Market. Goldman Sachs.
3. Sheetz KH, Norton EC, Dimick JB, Regenbogen SE. Perioperative Outcomes and Trends in the Use of Robotic Colectomy for Medicare Beneficiaries From 2010 Through 2016. JAMA Surg. 2020 Jan 1;155(1):41-49.
4. Virtual Incision data on file