ASTRO 2024 Reveals Barrigel™ Rectal Spacer is Safe and Effective in Prostate Cancer Radiation Therapy

Teleflex Incorporated, a prominent global provider of medical technologies, has unveiled new data affirming the safety and efficacy of Barrigel™ rectal spacer, the pioneering sculptable hyaluronic acid rectal spacer. Barrigel™ is specifically designed to minimize the radiation dose impacting the rectum during prostate cancer radiation therapy. This innovative device was highlighted in three abstracts at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting in Washington, DC.

Rectal spacers serve a critical role during prostate cancer radiation therapy by enabling precise radiation delivery to the prostate while protecting healthy rectal tissue. This is particularly crucial in hypofractionated treatment regimens, which involve delivering higher doses of radiation over fewer sessions. Unlike other rectal spacers that harden quickly, Barrigel™'s hyaluronic acid composition remains soft and pliable, allowing physicians to adjust and optimize rectal protection as needed. Additionally, it provides high visibility during transrectal ultrasound, ensuring optimal placement.

Prostate cancer is a significant health concern, with around 300,000 new cases expected in the U.S. this year. The incidence rate has seen a steady increase of 3% per year over the past decade. According to Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at Teleflex, the latest data from ASTRO 2024 demonstrates that Barrigel™ rectal spacer not only performs well in controlled trials but also in real-world settings, including repeat radiation therapy. Welch also noted that accidental injection errors can be safely reversed using hyaluronidase, a naturally occurring enzyme, an advantage unique to Barrigel™ compared to other spacers.

The first abstract, "Impact of Hyaluronic Acid (HA) Rectal Spacer Quality Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score on Rectal Dosimetry and Acute and Late Gastrointestinal (GI) Toxicity Outcomes – an Australian Experience," detailed the experience of 100 men in Australia receiving localized prostate cancer treatment with Barrigel™. The study revealed excellent implant quality and symmetry, with no significant acute or late GI toxicity reported. Only one patient experienced rectal wall infiltration (RWI), which was successfully reversed with hyaluronidase.

The second abstract, "Rectal Wall Infiltration (RWI) with Hyaluronic Acid Based Rectal Spacer Reversal Protocol," presented data from a larger cohort of 5,000 Australian men. The study identified a very low incidence (0.32%) of RWI, with no severe post-procedural GI symptoms among the affected patients. The majority of these cases were successfully managed with hyaluronidase, highlighting the reversible nature of Barrigel™.

The third abstract, "Hyaluronic Acid Rectal Spacer in Locally Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on Feasibility, Safety, and Toxicity," focused on 17 men undergoing repeat radiation therapy. The findings showed a high success rate in spacer placement and achieved adequate rectal separation, with minimal toxicity reported.

Michael Chao, MD, a Radiation Oncologist at the Olivia Newton John Cancer Wellness & Research Centre, emphasized that these studies provide robust evidence of Barrigel™'s safety and efficacy in routine clinical practice. Chao highlighted the rarity of RWI with Barrigel™ and the effectiveness of hyaluronidase in reversing these incidences, contrasting it with other spacers that lack this reversibility.

LaToya McLean, MD, from Thomas Jefferson University, noted that Barrigel™ offers a viable option for patients with recurrent prostate cancer who require repeat radiation therapy. The study demonstrated that Barrigel™ can be safely and effectively placed even in previously irradiated tissue, overcoming a significant barrier to treatment.

Barrigel™ rectal spacer, composed of Non-Animal Stabilized Hyaluronic Acid (NASHA), is approved for use in the United States, Australia, and Europe. It has been shown to significantly reduce side effects from prostate cancer radiation therapy and is specifically indicated for patients with T1-T3b prostate cancer.

Teleflex Incorporated continues to advance healthcare outcomes through innovative technologies like Barrigel™, underscoring their commitment to improving patient care in various medical fields.