Creo Medical Group’s MicroBlate™ Fine demonstrates success in pancreatic cancer patient
London-listed (CREO ) has reported positive results from the first in-human use of its 510(k) US FDA cleared tissue ablation device, MicroBlate™ Fine.
The medical device company, which is focused on the emerging field of surgical endoscopy, announced back in November 2020 that it had received 510(k) clearance from the US FDA.
A 510(k) is a premarket submission made to demonstrate that the stated device to be marketed is safe and effective and substantially equivalent to a legally marketed device.
MicroBlate™ Flex, a cleared tissue ablation device, became the third device within Creo's portfolio of flexible endoscopy devices for the gastrointestinal ('GI') market to receive FDA regulatory clearance, alongside CE marking already received across the range in 2020.
MicroBlate™ Fine uses high frequency microwave energy allowing physicians to precisely ablate diseased tissue in multiple organ types and many different clinical access methods.
Creo explained how the MicroBlate™ Fine has the same dimensions as a standard biopsy needle which, when used with typical EUS navigation tools, enables improved access to and the ablation of a wide range of organs (such as pancreas, liver, kidney, lung and muscle).
In today’s statement, Creo informed investors how the MicroBlate™ Fine device had been successfully used for the first in-human, minimally invasive, Endoscopic Ultrasound (EUS) guided, treatment in a patient with an unresectable pancreatic neuroendocrine tumour.
It said the procedure was performed by Dr. Carlos Robles-Medranda at Instituto Ecuatoriano de Enferemdades Digestives ("IECED"), Ecuador and the resulting outcome was successful.
Shares in Creo Medical Group have increased by 8% in value since the beginning of 2021. The stock was trading 4.85% higher this morning at 216p following the announcement.
‘With a condition that was not possible to be treated surgically using traditional methods, the patient required a less invasive treatment in order to potentially prolong the patient's life,’ it said.
Following the procedure, Creo said the patient ‘remains well and is enjoying life.’ It said subsequent scans of the patient's pancreas ‘continue to confirm the treatment's durability.’
Led By Dr. Carlos Robles-Medranda, IECED is the most advanced Gastroenterology and Digestive Endoscopy centre in Latin America and is endorsed by the World Endoscopy Organization (WEO) which leads the promotion of Endoscopy throughout the world.
Commenting on the MicroBlate™ Fine product, Dr Carlos Robles-Medranda stated: "I am excited about the potential of this technology for use in EUS guided therapy; the microwave energy allows me to precisely target and ablate difficult lesions. I believe this technology will have a positive impact on my patients, and I will continue to offer this treatment option."
CEO of Creo, Craig Gulliford said: “We are delighted to report such a positive update on our 510(k) US Food & Drug Administration cleared tissue ablation device MicroBlate™ Fine.
The device was successfully used for the first in-human minimally invasive EUS guided treatment in a patient with an unresectable pancreatic neuroendocrine tumour in December 2020. The outcome of the procedure was a success, with subsequent follow up scans not only showing no return of the tumour, but also an absence of any obvious scar tissue."
Creo’s first product to receive FDA clearance, a flexible endoscopy instrument named Speedboat™ Inject, is being used by clinicians in the UK, EU, US, South Africa and APAC.
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