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Virtual Incision Corp. last week announced that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration for its MIRA platform. The exemption will allow the company to initiate a clinical study of MIRA at a limited number of U.S. hospitals as it continues to seek regulatory approval. The surgical platform is an investigational device that is not yet available for sale in the U.S.
Lincoln, Neb.-based Virtual Incision said it is developing innovations to improve mobility, flexibility, and accessibility in minimally invasive surgical (MIS) procedures to provide option for more patients. The company claimed that MIRA, which stands for “miniaturized in vivo robotic assistant,” is the first of its kind. It is focusing first on colon resection, with follow-on specialty robots for additional potential applications.
MIRA designed to offer minimal size, cost
MIRA features a small, self-contained surgical device that is inserted through a single midline umbilical incision in the patient’s abdomen. Virtual Incision said its technology is designed to enable complex multi-quadrant abdominal surgeries using existing minimally invasive tools and techniques familiar to surgeons.
The system does not require a dedicated operating room or specialized infrastructure. Because of its small size, the device is intended to offer a cost-effective and accessible option for laparoscopic surgery.
“Because of its clear benefits for patients, the demand for robotically assisted surgery continues to increase, though challenges still inhibit broader adoption,” stated John Murphy, president and CEO of Virtual Incision. “MIRA is intended to overcome these limitations, with a simple and cost-effective solution that offers the potential to bring minimally invasive laparoscopic surgery to many more patients.”
“The IDE approval for MIRA is an exciting and critical next step that will allow us to evaluate the safety and effectiveness of this novel device in patients,” he said. “We look forward to working closely with the surgical teams and study sites to advance the MIRA surgical platform with the goal of making minimally invasive surgery more accessible.”
Minimally invasive procedures growing, could benefit from robotics
Colorectal and lower gastrointestinal procedures are among the fastest-growing surgeries in the U.S., with more than 400,000 colon resection procedures performed each year, said Virtual Incision. Minimally invasive colectomies have been shown to reduce mortality, and they can also reduce a patient’s healing time, pain, complications, and hospital readmissions.
However, manual laparoscopic colectomies, though also minimally invasive, can be difficult to perform and can have less than ideal cosmetic outcomes.
“Many benign and malignant conditions require removal of a portion of the colon,” said Dr. Dmitry Oleynikov, co-founder and chief medical officer of Virtual Incision. “Currently, the most common approach is open surgery, which involves a very large incision, a long hospital stay and several weeks of recovery.”
“Open colectomies carry a high risk of surgical site infection and other complications that can negatively affect a patient’s quality of life,” he noted.
“Despite significant technological advancements and improved patient outcomes that can reduce the total cost of care, adoption of minimally invasive colon surgery has been limited,” said Shane Farritor, Ph.D., co-founder and chief technology officer of Virtual Incision. “This milestone is a step toward a miniaturized solution to robotically-assisted laparoscopic surgery.”