AngioDynamics Announces Publication of DIRECT Study Results and New Category I CPT Code for Pancreatic IRE
Prospective, multicenter FDA IDE study found an IRE-based treatment strategy was associated with longer overall survival in Stage III pancreatic cancer; new Category I CPT code for open pancreatic IRE takes effect January 1, 2027
LATHAM, N.Y., October 21, 2026--AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options, and improving quality of life for patients, today announced two milestones for irreversible electroporation (IRE), the non-thermal ablation technology delivered by the NanoKnife System. The first is the publication of results from the DIRECT study in The Oncologist, in which an IRE-based treatment strategy was associated with longer overall survival in patients with Stage III pancreatic ductal adenocarcinoma (PDAC). The second is a new Category I CPT® code for open IRE ablation of pancreatic tumors, effective January 1, 2027.
DIRECT Study Publication
The peer-reviewed article reporting overall survival results from the DIRECT study was published in The Oncologist (DOI: 10.1093/oncolo/oyag416). DIRECT is a multicenter study conducted under a U.S. Food and Drug Administration Investigational Device Exemption at 18 U.S. sites. The analysis compared patients treated with standard-of-care systemic therapy plus IRE with patients who received standard-of-care systemic therapy without IRE for Stage III PDAC.
The analysis included 137 patients: 99 treated within an IRE-based strategy and 38 who received standard of care without IRE. Reported findings included:
Patients treated within an IRE-based strategy had a median overall survival of 28 months from diagnosis, compared with 15 months for patients who received standard of care without IRE.
After statistical adjustment for differences between the two groups, IRE remained associated with longer survival, including an average of five additional months of survival during the first 24 months.
Median progression-free survival was 9 months in the IRE group and 6 months in the standard-of-care group. Serious adverse events, defined as Grade 3 or higher, were reported in 56% of patients in the IRE group and 71% of patients in the standard-of-care group.
DIRECT was a non-randomized study and the findings should be interpreted as an association between the IRE-based treatment strategy and longer survival, rather than definitive evidence that IRE caused the observed survival difference.