The US Food and Drug Administration (FDA) has granted Miami-based medical device specialist, PorTal Access clearance for its range of implantable vascular access ports.
PorTal has designed the devices, which fall under the FLEXI-PORT family, to allow long-term, flexible access to a patient’s bloodstream through veins in the chest or upper arm – potentially reducing the patient discomfort associated with rigid titanium or hard plastic-based ports, while diminishing the need for continuous needle pricks to draw blood or administer intravenous (IV) treatments like chemotherapy.
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PorTal’s solution, which comes in two sizes, 5 and 6 French (5Fr, 1.67mm; 6Fr, 2mm in diameter), requires a small incision and is indicated for use in both adult and paediatric patients across various clinical settings.
According to the company’s head of business development and COO, Angela Dotson, FLEXI-PORT’s FDA clearance marks the “first true innovation in chemo ports” in more than three decades.
On its journey to FLEXI-PORT’s FDA clearance, PorTal secured 85% of its funding from physicians who currently either directly fit chemotherapy ports or refer patients for this procedure, and the company notes that the solution offers a “versatile” option designed to address “diverse clinician preferences and patient needs”.
With this FDA greenlight under its belt, PorTal will now forge on with its commercialisation efforts for FLEXI-PORT in the US, which will see the company boost its engagement with providers, partners, health systems and distributors, while providing training programmes for clinicians to facilitate safe use.
PICC ports gain steam
Since 1975, when clinicians first started using PICC lines as a longer-term solution to treating patients through IV, there have been multiple developments in long-term vascular access tools, with chest ports that overcome the maintenance challenges associated with PICC lines becoming a widely used method.
However, now arm ports, otherwise known as PICC-ports, are gaining notoriety due to their potential to simplify access for nurses administering therapy, while avoiding the need for chest puncture.
This could be particularly beneficial for patients with procedural anxiety who may have had “prior surgery, radiation or anxiety about chest interventions”, said Anthony Marshall, nurse practitioner at Protea Health Clinics, in a LinkedIn post.
However, Marshall noted that clinicians do need to make considerations around the use of PICC-ports, as there is a need for skilled specialists to insert such devices for correct vein and tip placement. He added that clincians may not be as familiar with arm ports compared with chest alternatives.
