The FDA’s View on CTO-PCI Devices Tara A. Ryan, MD, MS, MBA Division of Cardiovascular Devices Office of Device Evaluation Food and Drug Administration Good morning…..I have been asked to provide an update on the FDA’s view on devices that are used to treat chronic total occlusions.

I have no relevant financial relationships

Looking back Guide/Support Catheters - Microcatheters Guidewires – different flexibilities, lubricities, tip loads, tip shapes, etc. Guide/Support catheters & Guidewires – Class II devices, typically do not specifically mention CTO in labeled indications I thought it would be helpful to start by “looking back” at the some of the devices that are used for the treatment of CTOs and describe the route taken to achieve marketing clearance. First guide/support catheters – good guide support is certainly essential to achieve procedural success. Under this category comes are “micro-catheters” which are low profile, trackable, over-the-wire devices that are intended to assist with guide wire control and ease of wire exchange. Guidewire choice is another key element to treatment success. There are a number of available guidewires on the market with varying design properties that operators can choose for a treatment of a CTO lesions. These design properties include flexibility, lubricity, wire tip load, ability to shape the tip, tactile feedback, etc. All of these guide/support catheters and guidewires are Class II devices and obtain market clearance through premarket notification (510(k) ). Of note is the fact that typically these devices have not specifically mentioned treatment of CTO in the labeled indications in the 510(k) submissions. The next category is we categorize as specialty crossing devices……I will talk a little bit more about these in the next slide. And finally, new techniques involving dissection of the sub-intimal space and re-entry into the true lumen have led to specialized dissection/re-entry devices such as the StingRay System

Looking back (cont.) Specialty crossing devices -CROSSER® - Frontrunner® - OCR Safe-Cross® - CrossBoss™ Dissection/Re-entry devices (dissection into subintimal space and re-entry)

Specialty Crossing Devices Varying technologies Cleared through the 510(k) notification process Clinical data provided to support the CTO indication Indications for use – “Facilitating placement” of devices (guidewires) beyond chronic total occlusions”.

“Everyday” Devices EXPERT CTO Study HT PROGRESS and HT Pilot Guidewires Mini-Trek Balloon Dilatation Catheters XIENCE stents Briefly talk about EXPERT CTO study and how these devices got market clearance

Going Forward Dynamic changes in the CTO landscape Many “everyday” devices may be useful for the treatment of CTOs and may represent beneficial adjuncts to the armamentarium of the interventional cardiologist In recent years novel devices, refined imaging modalities and innovative techniques have increased success rate and safety of PCI for treatment of CTO remarkably.

Going forward (cont.) FDA encourages early interaction with the Agency to discuss plans that may include seeking a CTO indication for an already marketed device (or to include a CTO indication for a new device not yet on the US market)

Factors to Consider when Planning CTO Clinical Trials Device selection (adjunctive equipment can affect outcomes as well as device labeling) Patient/lesion selection Procedural techniques User experience

Thank you Tara A. Ryan, MD, MS, MBA Medical Officer/Biomedical Engineer Food & Drug Administration CDRH/ODE/DCD/ICDB Tara.Ryan@fda.hhs.gov