Milestone Scientific rolls out CompuFlo disposables for spinal cord procedures
11 Dec 2023
Drug ApprovalClinical ResultAHA
UTMB Health Clear Lake Campus Hospital adopted Milestone Scientific’s neurostimulation technology after a successful evaluation process, where the procedures using the CompuFlo disposables reported 100% success, without any complications
CompuFlo disposables are intended for spinal cord procedures. (Credit: Piron Guillaume on Unsplash)
US-based medical equipment provider Milestone Scientific has announced the commercial launch of its CompuFlo disposables for spinal cord implantation procedures.
The University of Texas Medical Branch (UTMB) Health Clear Lake Campus Hospital adopted the CompuFlo disposables for neurostimulation procedures.
Milestone said that the move expands the use of CompuFlo beyond the UTMB’s labour and delivery department and training for residents in epidural needle placement and verification.
The spinal cord stimulator is an implanted device designed to send low levels of electricity directly into the spinal cord to relieve pain.
UTMB adopted the neurostimulation technology after a successful evaluation of 10 cases, in which CompuFlo showed 100% success with no complications reported.
A part of the University of Texas System, UTMB is a major academic health sciences centre with medical, nursing, health professions and graduate biomedical schools.
UTMB neurosurgeon Patrick Karas said: “In my experience, Milestone’s CompuFlo helps to minimize the risk of intraoperative cerebral fluid leakage and trauma to underlying nerve roots, both potential complications of spinal cord stimulator procedures.
“Cerebral fluid leakage can require a post-operative blood patch, while nerve root irritation can cause severe radiculitis requiring extended post-operative admission and post-operative steroid injections.”
Earlier this year, Milestone has received an expanded US Food and Drug Administration (FDA) 510(k) approval for the CompuFlo Epidural System.
The CompuFlo Epidural System was previously approved in the US for use within the lumbar region of the spine, focusing on labour and delivery.
With the expanded FDA approval, the CompuFlo system can now be used in the thoracic region of the spine, including the cervical thoracic junction.
In a separate development, Milestone Scientific announced the pricing of an underwritten public offering of 4,765,000 shares of its common stock for $0.63 per share.
The medical equipment company is expected to receive gross proceeds, before underwriting discounts and commissions and estimated offering expenses, of around $3m.
Milestone Scientific CEO Arjan Haverhals said: “I am very pleased to announce that UTMB Health Clear Lake Campus Hospital has expanded the use of the CompuFlo Epidural beyond labour & delivery, to now include neurostimulation spinal cord stimulator implantation procedures.
“Use of our instrument for this procedure is further evidence of the broad potential of CompuFlo based on its ability to increase efficiency, safety and predictability, thus improving patient outcomes and lowering costs.”
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