06.08.15
Cardiovascular Systems Inc.'s orbital atherectomy technology can safely and effectively treat severely calcified lesions without a high risk of major adverse events, a clinical study has concluded.
The company recently released two-year data from its ORBIT II study of the Diamondback 360 Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions. Cardiovascular Systems (CSI) completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and efficacy of the company’s orbital atherectomy technology in treating patients with de novo severely calcified coronary lesions. ORBIT II was the first investigational device exemption study in history to evaluate this problematic subset of patients, according to company executives. In October 2013, CSI received pre-market approval from the U.S. Food and Drug Administration to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries.
Trial data demonstrated low major adverse cardiac events (MACE) rates, including target lesion revascularization (TLR) and target vessel revascularization (TVR), at two years for this difficult-to-treat patient population.
“ORBIT II two-year data reaffirms that CSI’s orbital atherectomy technology is a safe and effective treatment option for severely calcified arteries,” said Jeffrey Chambers, M.D., of the Metropolitan Heart and Vascular Institute in Minneapolis, Minn. “Results continue to show the clinical and economic benefits of this device. Furthermore, we now know that using the coronary OAS device prior to stent placement in severely calcified arteries has shown positive long-term results in a complex and problematic patient population.”
The study yielded the following two-year data:
Long-term Cost Effectiveness
The Diamondback 360 Coronary OAS has been associated with a lower length of stay for patients when the device was used to treat severely calcified lesions compared to treating without the Diamondback 360. A lower incidence of readmission and lower length of stay provide an estimated cost savings in excess of $3,100 per patient to the treating institution.
“The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries and CSI’s commitment to delivering innovative, durable and cost-effective solutions,” said David L. Martin, CSI president/CEO. “Coronary arterial calcium often results in poor clinical outcomes and higher treatment costs, but our two-year results demonstrate significant improvements in both of these areas when our orbital atherectomy technology is employed.”
Coronary artery disease (CAD) is a life-threatening condition and a leading cause of death in U.S. adults. 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. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events.
Based in St. Paul, Minn., Cardiovascular Systems develops and commercializes vascular and coronary disease treatments.
The company recently released two-year data from its ORBIT II study of the Diamondback 360 Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions. Cardiovascular Systems (CSI) completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and efficacy of the company’s orbital atherectomy technology in treating patients with de novo severely calcified coronary lesions. ORBIT II was the first investigational device exemption study in history to evaluate this problematic subset of patients, according to company executives. In October 2013, CSI received pre-market approval from the U.S. Food and Drug Administration to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries.
Trial data demonstrated low major adverse cardiac events (MACE) rates, including target lesion revascularization (TLR) and target vessel revascularization (TVR), at two years for this difficult-to-treat patient population.
“ORBIT II two-year data reaffirms that CSI’s orbital atherectomy technology is a safe and effective treatment option for severely calcified arteries,” said Jeffrey Chambers, M.D., of the Metropolitan Heart and Vascular Institute in Minneapolis, Minn. “Results continue to show the clinical and economic benefits of this device. Furthermore, we now know that using the coronary OAS device prior to stent placement in severely calcified arteries has shown positive long-term results in a complex and problematic patient population.”
The study yielded the following two-year data:
- MACE (two-year)*: 19.4 percent
- MI (CK-MB>3x ULN)*: 9.7 percent
- Non Q-wave: 8.8 percent
- Q-wave: 0.9 percent
- Target vessel/lesion revascularization: 8.1 percent
- TVR: 2.9 percent
- TLR: 6.2 percent
- Cardiac death: 4.3 percent
Long-term Cost Effectiveness
The Diamondback 360 Coronary OAS has been associated with a lower length of stay for patients when the device was used to treat severely calcified lesions compared to treating without the Diamondback 360. A lower incidence of readmission and lower length of stay provide an estimated cost savings in excess of $3,100 per patient to the treating institution.
“The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries and CSI’s commitment to delivering innovative, durable and cost-effective solutions,” said David L. Martin, CSI president/CEO. “Coronary arterial calcium often results in poor clinical outcomes and higher treatment costs, but our two-year results demonstrate significant improvements in both of these areas when our orbital atherectomy technology is employed.”
Coronary artery disease (CAD) is a life-threatening condition and a leading cause of death in U.S. adults. 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. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events.
Based in St. Paul, Minn., Cardiovascular Systems develops and commercializes vascular and coronary disease treatments.