Lake Forest, Calif. — Medical device company Single Pass Inc. has launched a major global post-market evaluation of its SinglePass™ electrocautery biopsy tract closure device. The study, known as B-S.A.F.E. (Biopsy with SinglePass: Assessing Fast & Effective Tract Closure), aims to collect real-world evidence from 1,000 biopsy procedures across 20 clinical centers worldwide.
The initiative is one of the most extensive data-gathering efforts to date focused on biopsy tract closure, addressing a critical concern in percutaneous solid organ biopsies—post-procedural bleeding. Although millions of such procedures are successfully performed each year, bleeding remains a common complication that can lead to additional interventions, longer hospital stays, and increased healthcare costs. In rare cases, complications can become severe.
The SinglePass device is designed to cauterize the biopsy tract immediately after tissue extraction, providing an efficient method for reducing bleeding risk, improving procedural safety, and optimizing patient recovery and observation time.
“Single Pass’s global post-market evaluation reflects our commitment to innovation backed by evidence,” said John Zehren, CEO of Single Pass Inc. “We’re honored to work alongside frontline clinicians to validate real-world safety, usability, and performance.”
The B-S.A.F.E. study will evaluate several metrics, including the reduction of post-biopsy bleeding and complications, improvements in workflow, and decreases in post-biopsy observation time.
Clinicians participating in the study have already expressed optimism about the device’s potential. “The SinglePass device represents a transformational advancement in the world of core needle biopsy,” said Dr. Alexander Misono, Chief of Interventional Radiology at Hoag Hospital Irvine. “With the ability of SinglePass to provide immediate and reliable tract closure, we are witnessing a shift in how we manage bleeding risk and patient recovery.”
Dr. Francis Kang, Clinical Chief of Interventional Radiology at Robert Wood Johnson University Hospital, echoed that sentiment: “I use SinglePass on every visceral biopsy for both tumor and parenchyma, including kidney and liver. This innovative device efficiently seals biopsy channels, significantly reducing bleeding risks and improving patient safety across all my biopsy procedures.”
The B-S.A.F.E. study is expected to strengthen the clinical case for integrating electrocautery tract closure into standard biopsy protocols, potentially shaping the future of interventional radiology practices worldwide.
