Teleflex Launches Barrigel Rectal Spacer in Japan Following PMDA Approval for Prostate Cancer Radiation Protection
核心洞察
Teleflex has launched Barrigel rectal spacer in Japan following regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), marking a key milestone in the company's global expansion strategy.
The hyaluronic acid-based device is the first and only sculptable non-animal stabilized hyaluronic acid rectal spacer proven to significantly reduce radiation reaching the rectum during prostate cancer treatment.
Clinical data shows 98 percent of treated men achieved at least a 25 percent reduction in rectal radiation exposure, with patients averaging an 85 percent reduction in rectal V54 Gy radiation.
Teleflex Incorporated has launched its Barrigel rectal spacer in Japan following regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), with initial cases already performed earlier this month. The device represents the first and only sculptable non-animal stabilized hyaluronic acid (NASHA (搜索)) rectal spacer proven to significantly reduce radiation exposure to the rectum during prostate cancer radiation therapy.
The launch comes at a critical time for Japanese healthcare, as prostate cancer was the most common cancer among men in Japan in 2022, with 104,318 new cases accounting for 18 percent of all cancer diagnoses nationwide. Barrigel rectal spacer is indicated for prostate cancer patients with T1-T3b disease.
Clinical Efficacy and Safety Profile
A U.S. clinical study demonstrated that 98 percent of men treated with Barrigel rectal spacer met the primary endpoint of achieving at least a 25 percent reduction in radiation to the rectum. Patients who met the primary endpoint averaged an 85 percent reduction in rectal V54 Gy radiation to the rectum. The device has proven superior in reducing acute and long-term Grade 1+ gastrointestinal toxicity at 3 and 6 months compared to control groups.
"Japan commercialization represents a key milestone in our global expansion strategy for the Barrigel rectal spacer," said Liam Kelly, Chairman, President and CEO of Teleflex. "This launch supports our mission to offer the next-generation, NASHA (搜索) rectal spacer that enables precise, symmetrical placement—providing physicians with effective and proven control over the shape and placement of the implant."
Technology and Clinical Advantages
The Barrigel rectal spacer is composed of Non-Animal Stabilized Hyaluronic Acid (NASHA (搜索)), a substance naturally present in the human body that is highly biocompatible and fully absorbable. The device temporarily positions the anterior rectal wall away from the prostate during radiotherapy, creating space to reduce radiation dose delivered to the anterior rectum.
Dr. Jun Itami, one of Japan's top radiation oncologists who directed training sessions in Chiba beginning in late May, highlighted the device's unique properties. "Barrigel rectal spacer is unique in that it does not impose time constraints during injection and offers excellent visibility under ultrasound. This allows physicians to monitor the injection in real time and place the required amount precisely where needed for each individual patient," said Dr. Itami. "As a result, a reliable distance between the prostate and rectum can be maintained, enabling safer and more robust radiation therapy planning, representing a new standard in rectal protection during radiation therapy."
Market Access and Implementation
The device is now available for purchase in Japan following regulatory approval, insurance coverage acceptance, and appropriate use criteria issuance by Japanese academic societies. Yoshiko Inoue, Teleflex Managing Director for Japan, emphasized the significance of the launch for Japanese patients.
"With the launch of Barrigel rectal spacer in Japan, more men will have access to a solution that helps minimize the rectal side effects of prostate cancer radiation therapy," Inoue said. "We're proud to support this important advancement and remain committed to educating healthcare professionals on the value of rectal spacing and its adoption throughout Japan."
Global Regulatory Status
Barrigel rectal spacer has been cleared for rectal spacing in the United States, Australia, Europe, and now Japan. The device is composed of biodegradable material that maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient's body over time.
The device should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. Potential complications include pain associated with injection, needle penetration of surrounding structures, local inflammatory reactions, infection, urinary retention, rectal mucosal damage, bleeding, constipation, and rectal urgency.