Authors: Lilah Goldberg, Nova Szoka, MD, FACS, FASMBS
Stryker received FDA approval for the SPY Portable Handheld Imaging (SPY-PHI) System in November 2019.
The SPY-PHI is a handheld imaging device for performing intraoperative fluorescence angiography. After intravenous injection of indocyanine green dye, the SPY-PHI facilitates real-time capturing and viewing of fluorescent images for the visual assessment of blood flow and the evaluation of tissue perfusion during various surgical procedures.
The SPY-PHI System consists of the following components: Imaging Head/Imager with an integrated light guide cable and the Video Processor/Illuminator (VPI), allowing clinicians to assess perfusion at a wide range of viewing distances in the operating room, providing highly detailed imaging at 1080p resolution and realistic color reproduction. Ambient light immunity and compact design permit use without disrupting activities around the surgical table.¹ Combining fluorescence signal information with white light imaging, the device has multiple visualization modes including white light mode, overlay mode, SPY Fluorescence mode and Color Segmented Fluorescence (CSF) Mode.
A series of clinical literature evaluations by the FDA provided the basis to support an expansion of the indications for use to include pediatric patients, one month of age and older.
Nguyen et al. assessed a total of 100 bowel anastomoses in 82 consecutive surgeries using ICG-FA from November 1, 2017 to December 15, 2019; in this cohort, there were no adverse reactions and one postoperative anastomotic leak. ICG-FA was administered intravenously, and the SPY Portable Handheld Imager (SPY-PHI) was used to objectively assess bowel perfusion. ICG angiography was successful, allowing for complete visualization of anastomotic perfusion in all patients. In the study, “implementation and routine use of ICG-FA were found to be safe and well-tolerated without side effects.”
The FDA determined the fluorescence imaging system is substantially equivalent to predicate devices. The SPY Portable Handheld Imager (SPY-PHI) was demonstrated to be equivalent to the SPY Portable Handheld Imaging (SPY-PHI) System and the SPY Elite Intraoperative Perfusion Assessment System.
Indications for use:
- Adult and pediatric patients one month of age and older
- Fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures
- Patients younger than one month of age
- Patients with iodine allergy
- Nguyen JMV, Hogen L, Laframboise S, Bouchard-Fortier G, Ferguson SE, Bernardini MQ, May T. The use of indocyanine green fluorescence angiography to assess anastomotic perfusion following bowel resection in surgery for gynecologic malignancies – A report of 100 consecutive anastomoses. Gynecol Oncol. 2020 Aug;158(2):402-406. doi: 10.1016/j.ygyno.2020.05.008. Epub 2020 May 15. PMID: 32423604.
SPY-PHI visualization modes: