Coronary Artery Disease
The coronary arteries, which supply blood to the heart muscle, are susceptible to the buildup of plaque, a condition known as coronary artery disease ("CAD"). If the coronary arteries become too blocked with plaque, cardiac tissue can become starved of nutrients and oxygen, resulting in severe chest pain known as angina. As artery narrowing becomes more severe, death of cardiac muscle downstream from the area narrowing, or blockage, can occur due to the lack of oxygen. The sudden death of this cardiac muscle can result in a myocardial infarction, commonly known as a heart attack.
Fantom® Sirolimus-Eluting Bioresorbable Scaffold
REVA's Fantom sirolimus-eluting bioresorbable scaffold is designed to provide the same acute benefits as permanent drug-eluting metal stents: open up the artery to restore blood flow and then support the artery through healing. However, once its acute job is complete, it resorbs (i.e., disappears) from the body over a period of time, restoring the natural movement and function of the artery. Fantom has thin scaffolds struts and a low crossing profile, which aid in its deliverability. The scaffold can be delivered either through the femoral artery in the groin or through the radial artery of the wrist. Radial delivery is an increasingly common approach to scaffold and stent implantation that minimizes complications from surgery, speeds procedure recovery time, and can decrease the patient's hospital stay.
The Fantom scaffold is completely visible under x-ray; non-REVA scaffolds are not visible. This visibility allows the physician to precisely position the scaffold in its intended location, ensuring complete coverage of the plaque. Once positioned in its intended location, Fantom is able to be expanded in one smooth and continuous inflation step, similar to traditional metal stents, minimizing the procedure time for the physician and the patient. And because it's visible, the physician can easily evaluate scaffold expansion, position, and contact with the vessel wall to ensure it is placed as intended.
REVA's Proprietary Polymer Family
Fantom is made from REVA's proprietary high-performance polymers that were developed specifically for scaffold performance. These polymers not only provide the scaffolds inherent visibility, they provide for excellent scaffold strength to restore blood flow and maintain the opening of the artery until it has healed.
The Fantom scaffold becomes embedded in the artery wall during healing and gradually loses strength and mass, allowing the artery to begin expanding and contracting approximately one year after implant. Over time the scaffold completely degrades into benign by-products that are eliminated from the body, leaving behind a healed and functional artery. This frees the patient from life with a permanent implant and restores the natural vascular function of the heart.
Optimal Drug Delivery
REVA's polymer also serves as the drug-delivery coating on Fantom, allowing the controlled release of the anti-proliferative drug Sirolimus, to minimize scar tissue formation after the scaffold is implanted. This drug delivery at the treatment site reduces the likelihood of restenosis, or re-narrowing of the artery, which can sometimes occur in the area of scaffold implantation.
The FANTOM II pivotal clinical trial is evaluating the safety and performance of the Fantom sirolimus-eluting bioresorbable scaffold, which was implanted in 240 patients in two cohorts between March 2015 and March 2016. Data from patients enrolled in the trial were used to submit an application for CE Marking in August 2016. CE Mark approval for the Fantom scaffold was received in April 2017.