The EB-J10 Scopes
A ground-breaking endoscopic advancement.
The PENTAX Medical Video Bronchoscope EB-J10 product range offers sharp and clear High-Definition image quality. Combined with a High-Definition processor offering i-scan technology, the bronchoscopes support faster detection, precise demarcation and support the adequate patient treatment.
The unmatched ergonomic design and flexibility of the bronchoscopes offer you ease of operation in daily use. Complying with increasing hygiene requirements and STERRAD® compatibility the EB-J10 bronchoscopes provide greater patient and user safety.
Sharp imaging for detailed visualization
• Offers fast and detailed bronchial system investigation
• Leads to more precise detection of abnormalities
• Supports precise demarcation of lesions or tumors
Designed for precise sampling
• Facilitates smooth and easy insertion of accessories for diagnosis and treatment
• Efficient removal of secretion and control of bleedings
• Strong suction even with accessory in place
Reliable for increased user and patient safety
• New single-use suction control valve to minimize cross-contamination
• STERRAD® compatibility: clearing of multidrug resistant and extreme drug resistant Mycobacterium
Unmatched ergonomic design for ease of operation
• New-design lightweight control body with ergonomically positioned suction valve, angulation lever, and remote control buttons
• Soft light guide cable for easy handling
• Easy maneuverability thanks to a very small distal tip bending radius
• Easy access to right upper lobe due to 210° tip deflection
Studies further validate safety, efficacy and an improved patient experience in use of the C2 Cryoballoon® Ablation System for primary treatment of Barrett’s esophagus
REDWOOD CITY, Calif. – May 9, 2017 – C2 Therapeutics marked Digestive Disease Week by releasing the results of clinical studies that help further validate the utility of the C2 CryoBalloon® Ablation System (CbAS) for ablation of Barrett’s esophagus.i
These include studies that suggest a shorter physician learning curve with CbAS than for radiofrequency ablation (RFA) therapy and less pain two days post-procedure than with RFA. Further studies demonstrate potential for CbAS in ablation of gastric antral vascular ectasia (GAVE) and esophageal squamous cell neoplasia (ESCN).
The CbAS is similar to RFA in being deployed with an endoscopic catheter but uses extreme cold instead of heat to destroy diseased tissue in the esophagus. In a procedure known as cryoballoon ablation, nitrous oxide (N20) cryogen is delivered through a handheld controller in combination with a self-sizing balloon catheter that is inserted into the working channel of a 3.7 mm therapeutic endoscope. The CbAS has been used in nearly 900 procedures to date.
The synopses of the study results released for Digestive Disease Week are:
Physician Learning Curve. Studies show that physicians must perform about 30 RFA procedures to overcome the effect of learning curve on treatment outcomes.1 This study aimed to determine the learning threshold for ablation of Barrett’s esophagus with the CbAS. The researchers analyzed prospectively collected cryoablation procedure data from patients with neoplastic Barrett’s esophagus treated at a single academic institution. They concluded that the learning curve effect for CbAS is reached at about 18 cases, after which efficiency plateaus.
Patient Experience. Two studies in the Netherlands2 compared post-procedural pain in 79 Barrett’s esophagus patients treated with RFA patients and 20 treated with focal cryoballoon ablation. In both studies, all visible Barrett’s esophagus was treated, including circumferential treatment of the gastroesophageal junction. Pain was assessed immediately after the procedures and by telephone on Day 2. Patients were asked to apply pain scores from zero (no pain) to 10 (worst pain possible). Immediately after the procedure, 53% of cryoballoon ablation patients reported severe pain (score greater than 3), versus 24% of RFA patients. However, on Day 2, 46% of RFA patients reported severe pain, versus 18% of cryoballoon ablation patients. “This could suggest a shortened pain course after cryoballoon ablation compared with RFA,” said the principal investigator Prof. Bas Weusten, Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands.
Treatment for ESCN. Esophageal squamous cell cancer arises from esophageal squamous cell neoplasia (ESCN) and is highly lethal. A multi-site study3 assessed the safety and efficacy of focal cryoballoon ablation for eradicating ESCN. Forty-two patients (98%) were successfully treated. Thirty-five of 40 patients (88%) had complete eradication of unstained lesions (USL) upon a single treatment session; five patients (12%) with persistent USL were successfully re-treated. Three developed superficial self-limited mucosal laceration upon balloon inflation; two of these were successfully treated three months later and one did not return. Dr. Gui-Qi Wang, Department of Endoscopy, Cancer Institute and Hospital Chinese Academy of Medical Sciences in Beijing, China stated, “Although longer-term follow-up data is pending, early results of our multicenter study suggest that focal cryoballoon ablation is safe, well-tolerated and highly effective in inducing complete endoscopic and histologic response.”
Treatment for GAVE. GAVE is an uncommon cause of upper gastrointestinal bleeding. Endoscopic management has been mainly thermoablative, but balloon cryoablation is emerging as an alternative. This multi-center study4 reviewed data from 10 patients with refractory GAVE who were treated with balloon cryotherapy. These were patients who continued to receive treatment for GAVE despite prior non-cryoballoon therapy. Each patient received one to four cryoballoon treatments (median two). Technical success was achieved in all patients. Follow-up endoscopy showed improvement in eight patients; one patient showed no improvement in the three months post-cryotherapy. No adverse events were reported. “Cryoballoon therapy is a feasible and safe modality that can be used to treat GAVE,” reports Dr. Amrita Sethi, Division of Digestive and Liver Disease, Columbia University Medical Center, New York, NY. “Further studies are needed to evaluate long-term outcomes for this modality and to compare results to standard therapies.”
Swipe Cryoballoon Ablation Technique. Ablation devices for dysplastic Barrett’s esophagus are effective, but none offer the attributes for widespread adoption because of length of procedure time and ease of use. Other factors include side effects and lack of predictability of ablation depth. This multi-center study5 evaluated the safety, feasibility and dose response of a novel swipe balloon catheter developed by C2 Therapeutics (to be marketed as the C2 CryoBalloon® 90 Ablation System), which delivers 3 cm of ablation in less than 60 seconds. The technique was tested in domestic swine and six human patients. The swipe technique delivered uniform and predictable ablation with mucosal and submucosal necrosis in animal and human esophagus. All the animals tolerated the ablations without difficulty and were able to eat and gain weight afterward. The human patients also tolerated the procedure without adverse events. Investigators concluded that because of its ease of use, the device merits further clinical study in treating dysplastic Barrett's esophagus.
“These studies reinforce C2 Therapeutics’ commitment to improving treatment for patients affected by Barrett’s esophagus and other diseases of the gastrointestinal system,” said Peter Garcia-Meza, President and CEO. “We continue to develop new design configurations to treat unmet needs in patients with diverse anatomy and disease characteristics. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers.”
1 George Kunnackal John, et al, Cryoballoon Ablation for Barrett’s Esophagus: A Prospective Single Operator Learning Curve and Time-Efﬁciency Study, TU1170, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017.
2 Sanne N. van Munster, et al, Post-Procedure Pain Associated with Endoscopic Ablation Therapy of Barrett’s Esophagus: Post-Hoc Comparison Between Radiofrequency Ablation and Cryoballoon Ablation, TU1186, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017.
3 Yan Ke, et al, Safety and Efficacy of Endoscopic Focal Cryoballoon Ablation for the Treatment of Esophageal Squamous Cell Intraepithelial Neoplasia, M01997, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017.
4 Anish Patel, et al, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) with Cryoballoon Therapy: A Case Series, MO1986, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017.
5 Brian E. Louie, et al, Evaluation of a Novel Swipe Cryoballoon Ablation System in Bench, Porcine, and Human Esophagus, MO2010, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017.
About Barrett’s Esophagus
Barrett’s esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett’s esophagus), putting patients at greater risk of developing cancer of the esophagus.
About C2 Therapeutics
Founded in 2007 and headquartered in Redwood City, California, C2 Therapeutics developed the C2 CryoBalloon® Ablation System for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s esophagus with dysplasia. Acquired by PENTAX Medical – a division of HOYA Group – in January 2017, C2 Therapeutics continues to innovate and enhance its C2 CryoBalloon® Ablation System as a new standard for simplicity in the eradication of esophageal disease.
For more information about C2 Therapeutics, please visit www.c2therapeutics.com.
Lisa R. Bichsel, VP of Marketing
i C2 CryoBalloon Focal Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s esophagus with dysplasia.
PENTAX Medical introduces SMART Medical’s G-EYE® technology across EMEA for enhanced adenoma detection
Hamburg, 9 March 2017 – PENTAX Medical EMEA announces its continued cooperation with SMART Medical to support the distribution and deployment of SMART’s G-EYE® technology integrated with PENTAX Medical’s HD+ systems to the EMEA market. The G-EYE system employs a permanently-integrated balloon at the tip of the conventional endoscope, which is moderately inflated during endoscope withdrawal and enhances colonoscopy detection capabilities by straightening intestinal folds, centralizing the endoscope optics and eliminating bowel slippage. The result is a significantly improved detection of pre-cancerous polyps (adenomas) and substantial clinical benefit1.
The G-EYE system provides an innovative solution for enhancing adenoma detection rate (ADR), meeting the demand for improved quality in colonoscopy. G-EYE allows increasing ADR and superior stabilization of the endoscope even at difficult locations such as the right colon and tight flexures. Combined with the more controlled withdrawal of the G-EYE system, this provides improved diagnostic and therapeutic capabilities and a faster and more controlled procedure.
Rainer Burkard, President EMEA, PENTAX Medical commented, “Both PENTAX Medical and SMART Medical Systems are committed to the distribution of the G-EYE System to increase ADR across the endoscopy community. At PENTAX Medical, we are pleased to offer the integrated solution of SMART Medical’s G-EYE technology with our innovative HD+ endoscopy systems. We believe it has the capabilities to transform current adenoma detection practices, which is a statement that has been validated through a prospective randomized multi-center study, supported by both companies.”
The study included 1,000 patients enrolled across 14 international centers of expertise to compare the detection rate of the G-EYE system with that of standard HD colonoscopy. Intermediate results of 480 patients presented outstanding ADR results, including a 45.6% increase in ADR and a 96.9% increase in the detection of advanced adenomas1. The system also received excellent clinical feedback throughout the study.
Prof. Ralf Kiesslich, HELIOS Dr. Schmidt Kliniken, Wiesbaden, Germany who is leading the multi-center study commented, “G-EYE detects significantly more adenomas than standard colonoscopy and reduces colonoscopy miss rates. The increased ADR, advanced adenomas, and adenomas per patient will ultimately impact surveillance intervals of patients undergoing colonoscopy.“
Professor Sauid Ishaq, from Russell’s Hall Hospital, Dudley, UK, was one of the clinicians involved in the G-EYE multi-center study. Describing his experience, he said, “…The G-EYE endoscope ensures the colon haustral folds are straightened, the endoscope optics are centered within the lumen, bowel slippage is avoided in difficult positions and the overall visibility is improved. In addition, the balloon can help stabilize the endoscope’s tip in difficult conditions. The clinical results of the G-EYE endoscope, together with the accessibility advantages, provide a solid ground for the G-EYE endoscope delivering a high-end solution for day-to-day routine colonoscopy.”
In combination with Smart Medical’s NaviAid AB™ through-the-channel balloon device, the G-EYE system also offers on-demand two-balloon endoscopy to meet the market requirement for small intestine procedures. Being a unique, complete solution, the G-EYE system in combination with NaviAid AB delivers additional complementary therapeutic and enteroscopic functions.
Gadi Terliuc, CEO, SMART Medical Systems Ltd. added, “While colonoscopy has long been the technique-of-choice for preventing and diagnosing colorectal cancer, it was well known that many adenomas were unfortunately missed during routine colonoscopy. There was a need for a new product or technique that could reveal missed and hard-to-spot lesions, which is where the G-EYE system excels, providing an almost 50% increase in ADR. Our extended partnership with PENTAX Medical, a market leader in the endoscopy field, can make the G-EYE a widely available solution and a new standard of care in colonoscopy.”
- UEG journal (Volume 4, Issue 5 suppl, October 2016); abstract of G-EYE multi-centre study “OP374 INCREASED ADENOMA DETECTION RATE BY G-EYE HIGH DEFINITION COLONOSCOPY IN COMPARISON TO STANDARD HIGH DEFINITION COLONOSCOPY- A PROSPECTIVE RANDOMIZED MULTICENTRE STUDY”
This product is currently only available in the EMEA region.
About PENTAX Medical
PENTAX Medical is a division of HOYA Group. Its mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence with R&D, regional sales, service, and in-country facilities around the globe.
For more information, please visit: www.pentaxmedical.com.
About SMART Medical Systems
SMART Medical Systems is a pioneer in the development and manufacturing of innovative medical devices in the field of gastro-intestinal (GI) endoscopy. Its proprietary technology enhances the performance and capabilities of existing endoscopy equipment, in an intuitive and cost-effective manner. SMART's CE Marked and FDA cleared NaviAid™ product family is commercially distributed in key global markets. Its G-EYE™ product (CE Marked, pending FDA clearance) is presently under commercialization in selected regions.
For more information, please visit: www.smartmedsys.com.
◾The i-scan imaging project
The i-scan imaging project is a collaborative initiative led by PENTAX Medical, working with with Key Opinion Leaders from throughout the endoscopic community. It aims to inform endoscopists of this exciting new technology and promote its use in routine clinical practice, helping to improve the quality of diagnostic endoscopy.
To explore more, please visit the www.i-scanimaging.com
◾Read Our Blog
The OPTIVISTA EPK‑i7010 High‑Definition Video Processor
The new premium solution for advanced endoscopy.
To learn more, please visit www.epk-i7010.com/ - Product microsite of PENTAX Medical EMEA (Europe, Middle East, Africa)
The SCOPEPILOT - The next generation 3D colon navigation system
SCOPEPILOT NCU-7000 is the next generation Navigation system technology by PENTAX Medical designed to provide a true 3D live representation of the colonoscope shape and position inside the patient´s bowel tract.
To learn more, please visit www.scopepilot.com - Product microsite of PENTAX Medical EMEA (Europe, Middle East, Africa)
The DEFINA EPK-3000 Video Processor
The compact sized DEFINA processor offers state-of-the-art HD images that lead to detection of epithelial changes. This is supported by i-scan which further enhances mucosal and vessel patterns as well as tumor margins by its smart usability. i-scan technology guides the user to the area that needs to be biopsied and supports in determining the area to be treated.
To learn more, please visit www.definasystem.com/ - Product microsite of PENTAX Medical EMEA (Europe, Middle East, Africa)
The “my PENTAX Medical” customer portal provides you with 24/7 access to all online services, including manual downloads, repair requests and tracking, as well as training and events registration.
To learn more, please visit www.mypentaxmedical.eu - Product microsite of PENTAX Medical EMEA (Europe, Middle East, Africa)