PLAZA MEDICAL CENTER OF FORT WORTH IS FIRST IN DFW TO USE NEW DIAMONDBACK 360® CORONARY OAS TECHNOLOGY FOR TREATMENT OF CORONARY ARTERY DISEASE
Plaza Medical Center of Fort Worth announced today that the hospital is the first in DFW, and one of the first in the country, to use the Diamondback 360® Coronary Orbital Atherectomy System (OAS) from Cardiovascular Systems, Inc. (CSI).
Interventional Cardiologist Farhan Ali, M.D., M.P.H., a partner at Heart Center of North Texas, first used the Diamondback 360® Coronary OAS technology during a procedure on Tuesday, August 12, 2014 at Plaza Medical Center of Fort Worth to treat 73 year-old Martha Monroe of Fort Worth. Monroe was referred to Dr. Ali with shortness of breath and was found to have Coronary Artery Disease (CAD), a life threatening condition. She received balloon angioplasty in the right coronary of her heart and a stent on the back of her heart to remove 99 percent blockages in those arteries. She was then scheduled for the procedure using the Diamondback 360® Coronary OAS to remove an additional heavily calcified blockage in the proximal and mid left anterior descending artery of her heart that could not be treated by traditional stenting. The procedure eliminated the need for Monroe to undergo open-heart surgery and allowed Dr. Ali to insert a stent to restore blood flow in Monroe’s arteries.
“With severe blockages like Ms. Monroe’s, the only previous options would have been medication-only therapy or open heart surgery,” said Dr. Ali. “In her case, this device was a true benefit, reducing her calcium build-up with an orbital diamond coated crown sanding away calcification and allowing a stent to be easily placed. Diamond’s truly were her best friend in this case.”
This technology is the first evidence-based, safe treatment approved by the FDA for severely calcified coronary lesions. Arterial calcium is a common occurrence and can lead to significant complications, with moderate to severe arterial calcium present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, commonly known as angioplasty, in the U.S.
The Diamondback 360® Coronary OAS uses a patented combination of differential sanding and centrifugal force to reduce arterial calcium that can cause complications when treating CAD. It is an eccentrically mounted 1.25-millimeter diamond-coated crown that sands away calcium in severely calcified coronary arteries, enabling stent deployment. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium, while healthy tissue flexes away. Calcium that is sanded away is microscopic and is reabsorbed into the body.
“At Plaza Medical Center of Fort Worth we pride ourselves on being on the leading edge of innovative cardiac care,” said Clay Franklin, CEO of Plaza Medical Center. “The Diamondback 360® Coronary OAS is a revolutionary technology for treating severely calcified coronary lesions. It is another example of how we are adopting the latest advances in technology to best serve our patients.”
At 30-days, the results from CSI’s ORBIT II clinical study showed that using the Diamondback 360® Coronary OAS technology exceeded the trial’s primary safety and effectiveness endpoints within one of the most challenging patient populations. The primary safety endpoint of 30-day freedom from major adverse cardiac events (MACE) rate was 89.6 percent and the primary effectiveness endpoint of procedural success was 88.9 percent. This large study of 443 patients at 49 U.S. medical centers supported CSI’s Premarket Approval (PMA) submission, and it was the first Investigational Device Exemption (IDE) study in history to support approval for treating severely calcified coronary lesions.
About Coronary Arterial Disease
Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes or family history of early heart disease.
About Plaza Medical Center of Fort Worth and North Texas Division of HCA Hospitals
Plaza Medical Center of Fort Worth, one of the 12 North Texas Division of HCA hospitals, was established in 1974. Located in the heart of the medical district, Plaza Medical Center is a 320-bed facility offering comprehensive diagnostic and treatment services. The hospital serves as a tertiary referral center not only for Tarrant County, but also numerous counties within a 90-mile radius, and offers cutting-edge diagnostic treatment services in a wide range of specialties and subspecialties, including Cardiac Care, Neurosciences, Oncology, Orthopedics and Specialty Surgery. For more information on Plaza Medical Center of Fort Worth, please visit www.plazamedicalcenter.com. For more information on the North Texas Division of HCA Hospitals, please visit www.hcanorthtexas.com.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a rapidly growing medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. To date, nearly 125,000 of CSI’s devices have been sold to leading institutions across the United States. The U.S. FDA granted approval for the use of the Diamondback 360® Coronary Orbital Atherectomy System on October 21, 2013. CSI aims to lead the industry with the Diamondback Revolution, a new movement providing innovative, evidence-based solutions that meet the demand for interventional cardiology treatments. For more information, visit the company’s website at www.csi360.com.