A series of orthopaedic and spinal procedures have been completed using the Vital 5 ReLeaf catheter in Logan, and Chicago, USA.
The catheter is designed to safely deliver a regulated flow of local anaesthetic to a patient’s surgical site in close proximity to neural elements for the treatment of postoperative pain. It has been specifically developed for spinal applications.
The US Food and Drug Administration (FDA) 510(k)-cleared Vital 5 ReLeaf catheter, designed by orthopaedic spinal surgeons Kern Singh, and Frank M. Phillips, is intended to deliver a continuous and controlled amount of local anaesthetic to the surgical site via its proprietary “leaf catheter” design. The catheter should provide directional dispersion of local anaesthesia, and directional wound drainage from the surgical site.
As well as spinal procedures, the device can be used in general surgery, cardio-thoracic, plastic, orthopaedic and neurosurgical procedures, according to a company release.
In addition, the catheter functions to simultaneously drain excess fluids from the operative site. “The unique design characteristics of the device make it uniquely suited to spinal applications”, states Kern Singh. Frank M Phillips, comments “With the ability to effectively manage post-operative pain, I see ReLeaf allowing more surgeries to be accomplished in outpatient settings.”
In addition to spinal procedures, the device has been used in more than 25 total knee arthroplasty procedures since October 2014. Orthopaedic surgeon, E Marlowe Goble of Logan, Utah comments on his experience with the device. “In this preliminary study without controls, the Vital 5 ReLeaf Catheter has improved Visual Analogue Scale pain scores and reduced narcotic consumption in the acute postoperative period with my patients, while providing effective wound drainage to minimise oedema and facilitate earlier mobilisation. In approximately one-third of patients, no adjunctive treatment for pain during the first 48 hours following surgery was required while the catheter was indwelling. This preliminary study suggests that the Vital 5 ReLeaf Catheter may be more successful in managing acute postoperative than other pain management protocols.”
The Vital 5 ReLeaf Catheter has the potential to significantly lower the cost of care following orthopaedic and spinal procedures. According to a company release, the delivery of local anaesthetic to the surgical site reduces post-operative narcotic consumption, facilitates earlier mobilisation and quicker discharge from the hospital while simultaneously improving patient pain scores and overall satisfaction.