Life-changing FDA cleared Creo device successful in adding months to patient’s life expectancy and well-being
Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, provides an update on its 510(k) US Food & Drug Administration (‘FDA’) cleared tissue ablation device MicroBlate™ Fine.
First in-human use update
Further to the announcement dated 9 December 2020, the device was successfully used for the first in-human, minimally invasive, Endoscopic Ultrasound (EUS) guided, treatment in a patient with an unresectable pancreatic neuroendocrine tumour. The procedure was performed by Dr. Carlos Robles-Medranda at Instituto Ecuatoriano de Enferemdades Digestives (“IECED”), Ecuador and the resulting outcome was successful. 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. The Company is delighted to report that, following the procedure using MicroBlate™ Fine, the patient remains well and is enjoying life. 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. When asked about his experience with the MicroBlate™ Fine,
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.”
MicroBlate™ Fine, was the third device to gain FDA regulatory clearance within Creo's portfolio of flexible endoscopy devices for the gastrointestinal (‘GI') market in November 2020, and is designed to be used with Creo’s CROMA Advanced Energy Platform, powered by Kamaptive™ full-spectrum adaptive technology. The MicroBlate™ Fine device utilises Creo's very high frequency microwave energy allowing physicians to precisely ablate diseased tissue in multiple organ types and many different clinical access methods. 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).
Craig Gulliford, Chief Executive Officer of Creo, commented:
“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.”
Full details of Creo’s product range can be found here:
http://www.rns-pdf.londonstockexchange.com/rns/8918P_1-2020-6-14.pdf
