C2 CryoBalloon™ Ablation System Validated As Effective, Durable And Well-Tolerated By Patients

Published: Jun 06, 2018

MONTVALE, N.J., June 6, 2018 /PRNewswire/ --PENTAX Medical Corporation, a healthcare industry leader in diagnostic and therapeutic endoscopy, announced today the results about the C2 CryoBalloon™ Ablation System's clinical efficacy, durability, and patient tolerability from various studies conducted in the United States, Europe and China during Digestive Disease Week® (DDW) in Washington, DC from June 2-5. The clinical studies provide further evidence that the C2 CryoBalloon treats Barrett's esophagus (BE) effectively and has low patient discomfort. Additionally, PENTAX Medical announces positive efficacy results and low complication rates for the ablation of Esophageal Squamous Cell Neoplasia (ESCN).

Both Barrett's esophagus and ESCN are precursors to esophageal cancer which is the 8th most common cancer and the 6th most common cause of cancer death in the world.i "These studies reinforce PENTAX Medical's belief in the high-levels of effectiveness and tolerability of the C2 CryoBalloon for treatment of Barrett's esophagus and squamous dysplasia," said Gerald W. Bottero, Global President of PENTAX Medical. "The results from the clinical studies announced earlier this week showcase our commitment to providing therapeutic solutions for the endoscopist, gastroenterologist, and surgeon. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers."

Efficacy and Durability of C2 Cryoballoon Ablation for Barrett's Esophagus
In a prospective clinical trial, consecutive BE patients with confirmed neoplasia (low-grade dysplasia, high-grade dysplasia, and/or intramucosal adenocarcinoma) were treated with the C2 CryoBalloon. 12-month results were published early this yearii and 2-year durability results were presented during DDW 2018.iii Eradication of dysplasia was found in 95 percent of patients at both 12-months and 2-years. No disease progression noted in a single patient at 2 years (N=41) and no patient required narcotic medication after Day 7 following treatment.

Efficacy of C2 CryoBalloon Ablation for ESCN
A prospective studyiv in China assessed the safety and efficacy of the C2 CryoBalloon for treating ESCN. This ongoing single-center trial involved 80 patients with moderate or high-grade intraepithelial neoplasia. At 3 months, 90 percent of patients exhibited complete response (CR; absence of MGIN or worse). CR was exhibited in 97 percent of patients at 12 months. No serious adverse events were reported. "Early results from the study suggest that the [C2 CryoBalloon ablation] of ESCN is safe, well-tolerated and highly effective."

Evaluating Tolerability of C2 CryoBalloon Ablation
Two separate multi-centered, prospective studies found patients experienced less post-procedure pain and need for narcotic medication. European clinicians conducted a multicenter, non-randomized cohort study that compared the tolerability of patients treated for Barrett's esophagus after both C2 CryoBalloon ablation and radio frequency ablation. Investigators found peak pain was lower after C2 CryoBalloon ablation (median VAS 2 vs 4, P<.01). Duration of pain was shorter after CryoBalloon ablation (median 2 vs 4 days, P<.01).v

U.S. Investigators conducted a multicenter, prospective trialvi evaluating the efficacy and tolerability of C2 CryoBalloon ablation for Barrett's. Investigators found median pain scores were 2.5 (IQR 1-5) immediately after treatment, decreasing to 2 at day 1 (IQR 0-3), and 0 at day 7 after initial C2 CryoBalloon ablation. Only 1.3 percent (p<0.0001) of patients required narcotic analgesics by day 7. The researchers concluded, "Multifocal nitrous oxide C2 CryoBalloon ablation is associated with a favorable safety profile with mild, short-lived pain."

Ablating Larger Areas of Barrett's Esophagus with New C2 CryoBalloon 90°
A study at five centers in The Netherlandsvii assessed the feasibility, safety and efficacy of C2 CryoBalloon 90° which allows ablation of a 90-degree section of the esophagus circumference over 3 cm in a single step. No significant adverse events occurred during the study. Median pain scores (visual analog scale) were 4 at day zero, one at day 1, and zero at days 7 and 30. The researchers said this pilot study found, the C2 CryoBalloon 90° "is feasible, safe and well tolerated in patients with flat dysplastic BE…and is a promising new modality for endoscopic eradication."

Cryoablation for GAVE treatment
A retrospective studyviii at three academic teaching centers looked at 21 patients with refractory gastric antral vascular ectasia (GAVE) who were treated with the C2 CryoBalloon. Technical success was achieved in 100 percent of the patients. At the 6-month follow-up endoscopy, 18 patients (86 percent) showed improvement. Patients were transfused an average of 1.75 units/month one year prior to C2 CryoBalloon ablation and an average of 0.31 units/month up to 6 months following C2 CryoBalloon ablation. No adverse events were reported. The researchers called CryoBalloon therapy "feasible, safe, and efficacious."

Indications
US ONLY: The C2 CryoBalloon 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.ix

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 endoscopy, informatics, speech, voice, and swallowing assessment 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. PENTAX Medical employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs. For more information, visit www.pentaxmedical.com.

The third-party trademarks used herein are trademarks of their respective owners.

i Philip R Taylor, Christian C Abnet, and Sanford M Dawsey, Squamous dysplasia - the precursor lesion for esophageal squamous cell carcinoma, Cancer Epidemiol Biomarkers Prev. 2013 April ; 22(4): 540-552. doi:10.1158/1055-9965.EPI-12-1347.

ii Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal Nitrous Oxide Cryoballoon Ablation with or without EMR for Treatment of Neoplastic Barrett's Esophagus. Gastrointest Endosc. 2018 Apr 4; pii: S0016-5107(18)30259-1. doi: 10.1016/j.gie.2018.03.024. PMID: 29626424

iii Canto MI. Safety, Efficacy, and Durability of Endoscopic Nitrous Oxide CryoBalloon Ablation for Eradication of Barrett's Neoplasia. To be presented via poster presentation during DDW 2018.

iv Ke, Y, van Munster SN, Chen J, Liu F, Zhao D, Li W, He S, Zhang Y, Dou L, Liu Y, Liu X, Xue L, Lv N, Dawsey SM, Weusten BL, Bergman J, Wang G-Q. Endoscopic CryoBalloon Ablation is Safe, Well Tolerated and Highly Effective in the Eradication of Esophogeal Squamous Cell Neoplasia. To be presented via oral presentation during DDW 2018.

v van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman J, Weusten BL. CryoBalloon Ablation of Dysplastic Barrett's Esophagus Causes Shorter Duration and Less Severe Post-Procedural Pain as Compared to Radiofrequency Ablation. To be presented via oral presentation during DDW 2018.

VI Canto MI, Abrams JA, Lightdale CJ, Trindade AJ, Dumot JA, Iyer PG, Diehl DL, Khara HS, Chak A, Chang KJ, Corbett FS, McKinley M, Samarasena JB, Shin EJ, Tofani CJ, Waxman I, Shaheen NJ. Post-Procedural Pain Profile Associated with the Use of a Novel Contact CryoBalloon Focal Ablation System for Neoplastic Barrett's Esophagus. To be presented via poster presentation during DDW 2018.

vii van Munster SN, Overwater A, Raicu G, Seldenrijk KA, Nagengast WB, Schoon EJ, Bergman J, Weusten BL. Safety, Tolerability and Dosimetry of a Novel Swipe CryoBalloon Device (90° - SCBA) for Ablation of Dysplastic Barrett's Esophagus. To be presented via poster presentation during DDW 2018.

viii Patel A, Trindade A, Khara H, Kumar S, Ansari N, Lee TP, Diehl D, Sethi A, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) With Cryoballoon Therapy: Multicentered Experience with 6 Month Follow-up. To be presented via poster presentation during DDW 2018.

ix In the European Union, The CryoBalloon Ablation System is indicated to ablate unwanted tissue in the gastrointestinal tract, including treatment of Barrett's Esophagus and squamous dysplasia with application of extreme cold. In the United States, the device is indicated for the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.

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SOURCE PENTAX Medical Company

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