Leading the Transformation of Cardiovascular Stents with Novel Bioresorbable Polymer Technology

REVA Medical

REVA Medical was founded in 1998 under the name MD3, Inc. In the early 2000s, the company name changed to REVA Medical, Inc. and redirected its focus to bioresorbable technology. REVA has grown rapidly since its inception twenty years ago and hopes to continue its growth around the world to help as many patients as possible.
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Coronary artery disease is the leading cause of the death in the world. Arteries that provide blood to the heart muscle can become clogged and decrease blood flow to the heart. A complete blockage, with no blood flow, is what causes a heart attack. For a number of years, the most advanced medical solution has been drug-eluting metal stents.

The metal stents are delivered by a balloon catheter to the artery to be opened at the point of the clog and hold it open while it heals. It takes about three months for the artery to heal itself and the metal stent remains in place for the rest of the patient’s life. This creates a risk for adverse cardiac events and puts limitations on the patient’s ability to have that artery treated again in the future.

The concept of bioresorbable scaffolds came into being to match the performance of a metal stent during that healing phase and then disappear from the body entirely. This will allow the body to return to its natural state, and it will, therefore, not be subject to the complications from the metal stent or the limitations on future treatments.

The first generation of the bioresorbable products was not wholly successful. Most had been made from off-the-shelf technologies that were then modified to try to accomplish the performance characteristics desired for a coronary application. All of the first generation products had significant limitations.

Fantom is a bioresorbable scaffold – or stent – designed by REVA Medical. It is currently REVA’s leading commercial product although the company has two others in development. The exceptional difference in the Fantom product is that it is made from the proprietary polymer called Tyrocore that was created by REVA in collaboration with Rutgers University.

Tyrocore was specifically designed for use in vascular tissue, and Fantom itself is a second-generation bioresorbable scaffold design. One unique aspect of the product, when compared to first-generation products, is that it is the only bioresorbable scaffold that is fully visible under x-ray. This is helpful for physicians who use x-rays to perform the implant procedure and locate the product accurately within the coronary artery.

Another differentiating aspect of the product is that the Tyrocore polymer is capable of being made into thinner scaffolds than any others that are commercially available. A thinner scaffold is both easier for the physician to deliver to the location of the blockage as well as making it easier for the artery to heal during those first few months. The final benefit of the Tyrocore polymer is that it has greater strength and flexibility than the other polymers that have been used, making the scaffold much easier to use.

Before drug-eluting metal stents, the state of the art technology that was emerging at that time was for bare metal stents. The company developed a design that it believed would function better than the product that was available on the market and quickly realized that metal was not an ideal solution.

The process of finding its polymer took a few years, and by 2005, the company had in-licensed its unique polymer technology and begun developing its first-generation product called ReZolve. This continued until 2014 when REVA discovered more improvements that could be made to the design, resulting in the Fantom bioresorbable scaffold. In 2017, REVA achieved European regulatory approval with CE Mark and launched Fantom commercially in Europe.

CE Mark is a certification that proves a product’s conformity to health and safety standards. The clinical trial that resulted in the CE Mark for REVA was conducted in Europe, Australia and Brazil. CE Mark opens the door to different countries; REVA began with Germany, Austria, Switzerland, and Turkey, and during the course of 2018, it plans to expand both within Europe to countries like Italy and outside of Europe to countries that accept the CE Mark. REVA has also established a regulatory application of Fantom in Brazil, where the CE Mark is not used, yet its clinical trial data is still accepted.

Countries such as the United States, Canada, Japan and China all require additional clinical studies to secure regulatory approval of a medical product. “We are in the process of our discussions with the FDA today on what it will take for us to be able to start a clinical trial in the U.S., and we are cautiously optimistic that we will have approval on a trial design by the end of this year,” says Reggie Groves, CEO of REVA Medical.

REVA is in the early stages of growing from a single-product company to a multi-product company. Its third-generation scaffold named Fantom Encore will have improved features based on advanced manufacturing techniques, and it is working towards its first peripheral scaffold for below-the-knee vascular intervention. In May of this year, it will release the two-year clinical trial results from its FANTOM II pivotal trial, and it is also expanding its clinical program to include more patients with more complex diseases. The company is considering embolic beads as another new venture. These are used to treat tumors or growths where blood supply needs to be intercepted and/or deliver chemotherapy.

REVA chooses its endeavors carefully and looks for opportunities to make a radical positive impact on the lives of patients. Bioresorbable scaffolds will certainly accomplish that. “We believe very strongly that, although drug-eluting metal stents are incredible and have done wonderful things for patients, bioresorbable is the right answer for today,” says Reggie. REVA wants to be a part of the revolution that brings the benefits of bioresorbable technology to all patients, for both coronary and peripheral arteries.

REVA Medical employs fifty people at its facility in San Diego, California and has six employees working overseas in Europe. These employees form a highly-talented team that truly believes in the mission of the company: to restore patient health through the application of biomaterials. Many of its employees have been at REVA for over ten years.

“Now, we are in a leadership position. We are the only company with a novel proprietary bioresorbable polymer,” says Reggie of Tyrocore. Last year, Rutgers and REVA were recognized for their collaboration in creating the Tyrocore polymer by the Research and Development Council of New Jersey with the Edison Patent Award. REVA has extensive patent coverage. “We have nineteen biomaterial polymer families patented internationally, and our patents cover vascular scaffolds, embolics, orthopedics and drug delivery,” says Reggie.

REVA has faced and overcome many obstacles over the years. Its first major challenge was its work with the polymer, as it is difficult to make a plastic product behave like metal. REVA partnered with Rutgers University to seek a specific polymer design to use and spent over ten years determining how to manufacture the polymer into a scaffold with the desired characteristics. The second challenge for REVA was turning the polymer into an actual product that physicians are able to implant properly and that performs well in the human heart.

“Patients always come first. We need to make sure that what we are doing is in the best interest of all patients,” says Reggie.

REVA values integrity within the company and believes that honesty and open communication with both customers and investors about its products and the clinical evidence is essential for future growth in the industry. Known for its tenacity, it continues to overcome the various challenges along the way and persistently improves its product to enhance the quality of life for patients who require cardiovascular stents. “We believe in the ability of these biomaterials to truly impact the lives of patients, and we are not going to let any hurdles stop us,” says Reggie.

The transition from permanent metal stents to bioresorbable scaffolds is in motion as a result of the many benefits of a scaffold with the ability to disappear within the body. “There is a revolution underway in cardiovascular stents, and we believe that we are leading that transformation as we are the only company with a proprietary bioresorbable polymer that we think can achieve the full potential of bioresorbable technology,” says Reggie.

June 19, 2018, 5:45 PM EDT

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