Medtronic’s Chameleon PTA Balloon Catheter Studied for Fistula and Graft Maintenance Procedures

January 27, 2021—Joel Crawford, MD, et al recently published findings from a study of the Chameleon percutaneous transluminal angioplasty (PTA) balloon catheter (Medtronic) online in The Journal of Vascular Access (JVA). The investigators conducted a comparison of the Chameleon balloon catheter for fistula and graft maintenance procedures versus a standard PTA balloon.

Commenting on the study to Endovascular Today, investigator Tony P. Gasparis, MD, stated, “This study has demonstrated the advantage of having a therapeutic device with diagnostic capabilities. The Chameleon’s integrated injection port allows reduction in contrast dose, fluoroscopy time, and procedure time.” Dr. Gasparis is from Stony Brook Medical Center in Stony Brook, New York, where he is Professor of Surgery–Division of Vascular Surgery. He is President-Elect of the American Venous Forum.

As described in JVA, the incidence of cephalic arch (CA) and central venous (CV) stenosis has been reported in the range of 30% in the literature. The purpose of the study was to compare contrast use, fluoroscopy time, and procedure time in standard imaging by injection of contrast through the access sheath versus injection of contrast through the novel Chameleon PTA balloon with an integrated injection port.

The investigators performed a multicenter, retrospective evaluation of consecutive patients treated for CA and CV stenosis. They captured data including demographics, comorbidities, lesion characteristics/location, procedural details, volume of contrast used, fluoroscopy time, and procedure time. The study enrolled 68 consecutive patients.

In the control group (n = 34), imaging and treatment were performed using standard practice of pre- and postprocedural imaging through the sheath and intervention using a standard PTA balloon.

In the treatment arm (n = 34), imaging and treatment were performed using the Chameleon PTA balloon catheter.

Patient characteristics included the following:

• There were no significant sex or age differences between groups. The average age was 65.2 versus 66.5 years (P = .284) in the standard PTA group and the Chameleon group, respectively.
• The prevalence of comorbidities of hypertension, coronary artery disease, and diabetes was similar to national rates in both groups.

The investigators found that procedure time, fluoroscopy time, and contrast volume in the Chameleon group were significantly less when compared by multiple regression to the standard PTA group, correcting for potential confounders.

Specifically, the use of the Chameleon PTA balloon resulted in the following benefits:

• 34.2% reduction in procedure time (11.7 vs 7.7 min; P = .0008)
• 27.7% reduction in fluoroscopy time (118.4 vs 85.6 sec; P = .018)
• 49.1% reduction in contrast volume (30.6 vs 15.9 mL; P = .0001)

In JVA, the investigators concluded that the use of the Chameleon PTA balloon with an integrated injection port shows potential for a significant reduction in contrast dose, fluoroscopy time, and procedure time.