Business
FDA Clearance for HS1 Haemostasis Device
FDA Clearance for HS1 Haemostasis Device.
About this update from Creo Medical Group Plc
[{"type":"text","content":"\n \n \n RNS Number : 1176H\n Creo Medical Group PLC\n 23 March 2020\n \n \n \n \n \n \n \n The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (\"MAR\"). Upon the publication of this announcement via Regulatory Information Service (\"RIS\"), this inside information is now considered to be in the public domain.\n \n \n \n \n \n Creo Medical Group plc\n \n \n (\"Creo\" or the \"Company\")\n \n \n \n \n \n \n US FDA Clearance for HS1 \n \n Haemostasis Devic\n e\n \n \n \n \n \n Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the US \n Food & Drug Administration ('FDA') for its HS1 \n Haemostasis device ('HS1'). The HS1 will be used with Creo's \n CROMA Advanced Energy Platform ('CROMA') and alongside the already FDA-cleared Speedboat device.\n \n \n \n \n \n This news represents a significant milestone for the Company, being the first of a number of expected regulatory clearances which will bring a suite of devices to the flexible endoscopy markets in the EU and USA. \n \n \n \n \n \n Creo's haemostasis technology offers exceptional levels of precision and is the only non-stick haemostasis device currently available across all electrosurgical markets. HS1 is the first incarnation of this technology in a single use device for endoscopic use and combining injection therapy. This enables the HS1 to be used to stop bleeding during treatments for peptic ulcers, dieulafoy lesions, Mallory-Weiss tears, bleeding polyp stalks, arteriovenous malformations and angiomata.\n \n \n \n \n \n This is the second device to gain FDA regulatory clearance within Creo's wider portfolio of flexible endoscopy devices for the gastrointestinal ('GI') and pulmonary markets. CROMA has a heavily patented combination of bipolar radiofrequency ('RF') energy optimised for precise tissue dissection, with microwave energy for precision coagulation and tissue ablation. Powered by patented software controlled adaptive technology, CROMA enables intuitive, easy-to-use advanced devices such as Speedboat, HS1 and its pipeline of complementary endoscopic devices for resection, di...