FDA Clears Levita Pediatric Surgery System | MARS System First Case

Levita Magnetics Receives FDA Clearance for Pediatric Magnetic Surgery, Pioneering Less Invasive Procedures

A groundbreaking advancement in pediatric surgical care has arrived with FDA clearance of Levita Magnetics’ Magnetic surgical System (MSS) for use in children, marking the first U.S. pediatric submission of magnetic-assisted surgical technology. Surgeons at Cleveland Clinic Children’s successfully completed the inaugural pediatric procedure utilizing Levita’s MARS® System in conjunction with the newly cleared MSS, performing a laparoscopic cholecystectomy.

The innovative technology employs external magnets to precisely manipulate surgical instruments internally, substantially reducing the number of incisions traditionally required in laparoscopic surgeries. this approach promises faster recovery times and reduced trauma for young patients.

Did you know? – Magnetic-assisted surgery reduces the need for large incisions, potentially minimizing post-operative pain and scarring for pediatric patients.

“For pediatric patients, minimizing surgical trauma is critical-less pain, faster recovery, and fewer scars all contribute to better long-term physical and emotional outcomes,” explained Dr. Miguel Guelfand,professor and head of pediatric general and thoracic surgery at Cleveland Clinic Children’s.

The MARS System leverages Levita’s proprietary Dynamic Magnetic Positioning® technology to enhance surgical precision and minimize invasiveness. By utilizing magnetic retraction of organs and soft tissue – eliminating the need for additional fixed ports – the system improves visualization and control while substantially decreasing surgical trauma. This allows for a more controlled and less disruptive surgical experience.

“This clearance marks a defining moment for the future of surgery,” stated Dr. Alberto Rodriguez-Navarro, surgeon and CEO of Levita Magnetics.”By expanding magnetic-assisted, minimally invasive surgery to children, we’re setting a new standard in safety and recovery-reducing trauma, accelerating healing, and improving quality of life for patients and families. This is not just technological progress; its progress in compassion. Our vision is a future where every patient, irrespective of age, benefits from safer, more intelligent, and truly human-centered surgical care.”

Pro tip: – Minimally invasive surgery, like that offered by Levita, often leads to shorter hospital stays and a quicker return to normal activities.

This milestone solidifies Levita Magnetics’ position as a leader in surgical innovation, building upon a history of clinical firsts throughout the U.S. and Latin America. The company’s commitment to developing technologies that deliver tangible benefits to patients and their families is clearly demonstrated by this advancement in pediatric care.

Levita Magnetics, a Silicon Valley-based medical technology company, specializes in minimally invasive platforms that utilize magnetics to enhance precision and reduce invasiveness. The MARS system,when paired with the MSS,is currently FDA-cleared for gallbladder,bariatric,prostate,colorectal,and hiatal hernia procedures in both adults and adolescents. Together, thes systems facilitate less invasive, controlled abdominal surgeries through the combination of Dynamic Magnetic Positioning and advanced instrumentation.

The FDA clearance specifically allows for the use of the Magnetic Surgical system in laparoscopic cholecystectom

Reader question: – how might this technology impact the training of future surgeons,and what new skills will they need to acquire?

Explanation of Changes & Answers to Questions:

* Why: Levita Magnetics received FDA clearance to expand the use of its Magnetic Surgical System (MSS) to pediatric patients. This allows for less invasive surgical options for children.
* Who: Levita Magnetics, surgeons at Cleveland Clinic Children’s (specifically dr. Miguel Guelfand and Dr. Alberto Rodriguez-Navarro), and pediatric patients are the key players.
* What: The FDA cleared Levita Magnetics’ MSS for use in children,enabling magnetic-assisted,minimally invasive surgery for pediatric procedures. The first procedure performed was a laparoscopic cholecystectomy (gallbladder removal).
* How did it end?: The article ends with the FDA clearance being granted, allowing for the