Frequently Asked Questions
Answers to the most frequently asked questions about FreedomFlow™ and orbital atherectomy system.
What is an atherectomy?
Atherectomy is a medical procedure to remove the build-up of plaque on the walls of an artery, which can reduce or block blood flow to a limb or organ. It is usually performed by inserting a catheter into the vessel and using a special device to cut, scrape, or grind the blockage away.
What is orbital atherectomy?
- Directional atherectomy devices use a shaving technique to cut and remove the plaque.
- Rotational atherectomy devices use a rotating blade or diamond-coated burr on the tip of the device to cut or sand the plaque away.
- Orbital atherectomy devices use a diamond-coated sanding element that is attached to the side of the device; the element is then rotated in an orbital (eccentric) technique that enables it to adjust to the size of the vessel being treated.
- Laser atherectomy devices use light energy to vaporize the plaque.
What conditions will FreedomFlow treat?
Cardio Flow is developing a new orbital atherectomy device—the FreedomFlow Orbital Atherectomy System—that will provide physicians with a way to remove or modify all types of blockages—including calcified and fibrotic plaque—in a wide range of vessel diameters.
Who invented Cardio Flow’s FreedomFlow technology?
Cardio Flow’s FreedomFlow technology was developed by the late Dr. Leonid Shturman, inventor of the first-generation orbital atherectomy devices, which are manufactured and marketed by Cardiovascular Systems, Inc.
Dr. Shturman was working on the next generation device at the time of his death, and Cardio Flow owns Dr. Shturman’s extensive intellectual property portfolio for this new technology, including 27 issued and 1 pending patents.
When will FreedomFlow be available on the market?
Cardio Flow received an Investigational Device Exemption (IDE) approval for their FreedomFlow™ Orbital Atherectomy System First-in-Human (FIH) clinical trial from the U.S. Food and Drug Administration (FDA) in November, 2017. Cardio Flow will soon begin enrolling patients for this FIH study.
Development Plan Milestones
|Updated design for over-wire application||October 2016||Completed|
|Feasibility cadaver study||November 2016||Completed|
|Feasibility animal study||November 2016||Completed|
|Complete design||December 2016||Completed|
|Design Freeze/Design Verification Testing||February – April 2017||Completed|
|Animal study||March 2017||Completed|
|Cadaver study||April 2017||Completed|
|FDA FIH IDE submission*||August 2017||Completed|
|FDA IDE approval||November 2017||Completed|
|FIH clinical trial enrollment||Q4 2017||On schedule|
|FIH 30-day follow-up||Q1 2018||Anticipated|
*First-in-Human (FIH) Investigational Device Exemption (IDE) – FDA application for approval to begin clinical study to gather data on safety and effectiveness