Creo Medical has today announced that Speedboat Inject is now CE marked according to the Medical Device Regulation (“MDR”) for use throughout the entire gastrointestinal (“GI”) tract, having received upper GI clearance.

Until now, Speedboat Inject has been CE marked for lower GI tract use only within European markets. Clearance for upper GI procedures mean that the device can now be used for endoscopic procedures through the whole of the GI tract, from the mouth down to the stomach (upper GI tract) as well as within the lower GI tract. Speedboat Inject is already cleared and used in the full GI tract for the cutting and coagulation of soft tissue using radiofrequency (RF) and microwave energy in the US, APAC and elsewhere.

When used as indicated for the cutting and coagulation of soft tissue, Speedboat Inject has been used to perform procedures such as:

• Oesophagus per-oral endoscopic myotomy (“POEM”) to treat achalasia (a swallowing disorder), where typically a heller myotomy (surgery) would be required;
• Gastric per-oral endoscopic myotomy (G-POEM) to treat delayed gastric emptying (gastroparesis);
• Z-POEM to treat Zenkers diverticulum, where a pouch or pocket that forms in the wall of the oesophagus, affecting the throat and swallowing process, and is a prominent procedure for ear, nose, throat (ENT) and foregut surgeons;
• F-POEM, a derivative of Oesophagus POEM, to reduce reflux – typically this has required an invasive upper GI surgical procedure; and
• Speedboat Submucosal Dissections (“SSD”) in the stomach and oesophagus, to endoscopically resect certain cancerous and pre-cancerous lesions.

In FDA regions, upper GI cases account for over 40% of global Speedboat procedures to date. Creo Medical already has a healthy pipeline of clinicians ready to use the device for upper GI procedures across Europe, with demonstrations, training and procedures already planned in.

Craig Gulliford, Chief Executive Officer of Creo Medical, commented:

“We are really excited by this extension to the clearance in Europe which opens up increases in case volume for a significant number of our customers with usage to treat a wide number of additional indications. This clearance opens up possibilities not only to increase the caseloads of existing users, but primarily to introduce Speedboat to a large base of new users.

“Training doctors for Speedboat use in upper GI procedures has proven to be efficient in the USA. With our Pioneer programme now well established, and with some of the world’s finest upper GI endoscopic practitioners championing the device and providing mentoring, we have great capacity now to transition doctors through our Pioneer training programme and for them to become high users with training opportunities in multiple procedures with many different types of patients.

“I’m also delighted that this clearance has been done under the significantly changed regulatory framework (MDR) which has been a significant challenge for the team. This successful approval for Speedboat Inject according to the MDR represents a significant achievement for the Company and the team who have been working hard to secure this, building on the success we’ve already achieved in the US and APAC where Speedboat has been treating a wide range of upper GI procedures with excellent outcomes.”

Dr Zaheer Nabi, a frequent user of Speedboat Inject for upper GI procedures at AIG Hyderabad Hospital in India said:

“The advanced bipolar energy makes cutting and tunneling during POEM procedures very precise, providing me with improvements in efficacy and efficiency. I’ve also found that the design of the device significantly lowers the risk of perforation during such 3rd Space Endoscopic procedures, with the microwave energy effective in minimising bleeds and thermal damage. The slimmer device in particular is excellent for performing upper GI procedures.”

Another prominent user, Dr Jawaid from Baylor College of Medicine Medical Center in the US, added:

“Speedboat is effective in POEMs in particular because it can speed up the tunneling process and prevents inadvertent thermal injury. It may also help with post-procedural pain.”

Dr. Yip, from the Division of Upper GI and Metabolic Surgery at the Faculty of Medicine, Chinese University of Hong Kong said:

“The Speedboat device is a new revolution to the field of third space endoscopy and advanced tissue resection. With the novel bipolar and microwave energy platform, upper GI ESD/SSD and tunnelling procedures can be performed safely and efficiently, thus benefitting patients worldwide by enabling easier adoption of the technique.”