Nectero Medical Secures CPT Codes for Investigational AAA Treatment as Phase 2/3 Trial Shows Promise
核心洞察
Nectero Medical (搜索) received two Category III CPT codes from the American Medical Association for its investigational EAST system, facilitating future billing and reimbursement for treating small- to medium-sized abdominal aortic aneurysms.
The EAST system delivers pentagalloylglucose (搜索) directly into aneurysmal walls via a dual-balloon catheter, designed as a one-time endovascular treatment to slow or stabilize AAA growth.
One-year follow-up data from the stAAAble trial showed 91% of patients experienced aneurysm growth rates below expected levels compared to historical controls.
Nectero Medical (搜索) announced that the American Medical Association's CPT Editorial Panel has approved two Category III CPT codes for its investigational endovascular aneurysm stabilization treatment (EAST) system, marking a significant step toward future reimbursement and clinical adoption for treating small- to medium-sized abdominal aortic aneurysms (AAAs).
The newly approved codes will facilitate physician and hospital billing and reimbursement for treatment with the Nectero EAST system in clinical practice, applicable to procedures performed via both percutaneous and open approaches. Category III CPT codes are specifically designated for emerging technologies, services, and procedures.
"This approval is a meaningful step forward in validating our technology and preparing for reimbursement," said Jack Springer, President and Chief Executive Officer of Nectero Medical (搜索). "It reflects extensive collaboration with multiple medical societies to build consensus and define the procedure accurately."
Addressing an Unmet Medical Need
Small- to medium-sized AAAs (3.5–5.0 cm in women, 3.5–5.5 cm in men) are typically managed with imaging surveillance, as no proven therapeutic interventions currently exist for this patient group. Once an AAA reaches a critical size, open surgery or endovascular repair becomes warranted—but both carry significant procedural risks. The ability to slow aneurysm growth and delay or avoid invasive procedures would represent a major advancement in patient care.
Novel Treatment Mechanism
The Nectero EAST system is an investigational, one-time endovascular treatment designed to slow or stabilize the growth of small- to medium-sized AAAs. It delivers a pentagalloylglucose (搜索) (PGG) drug solution directly into the aneurysmal wall via a dual-balloon catheter. PGG binds to elastin (搜索) and collagen, reinforcing those structural proteins which may strengthen the aortic wall, hinder enzymatic degradation, slow the growth of aneurysms and potentially reduce rupture risk.
The procedure leaves no permanent implant behind and does not preclude future interventions if needed.
Clinical Trial Progress
The Nectero EAST system is currently being evaluated in the phase 2/3 stAAAble multicenter, randomized clinical trial assessing safety and efficacy in patients with small- to medium-sized AAAs. The FDA granted investigational new drug clearance for the trial in July 2023, and the company commenced the study in January 2024.
The IND submission was supported by a prospective, first-in-human study of 46 patients treated outside the U.S., which demonstrated that a single, localized administration of pentagalloylglucose (搜索) was safe and showed the potential to slow aneurysm growth.
Promising Early Results
One-year follow-up results of the full cohort of patients from the stAAAble trial were presented in April at the Charing Cross International Symposium 2025. The data showed a significant reduction in aneurysm diameter growth compared to historical control data, with 91% of patients growing at less than the expected growth rate.
These results suggest the potential for the EAST system to address a significant gap in AAA management, offering a treatment option for patients who currently have no therapeutic alternatives beyond surveillance until their aneurysms reach sizes requiring high-risk surgical intervention.