March 7, 2013 — Cardiovascular Systems Inc. (CSI) presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT) conference.
The ORBIT I study evaluated the safety of CSI’s orbital atherectomy system as a treatment for mild to severely calcified coronary arteries. Results from the 50-patient feasibility trial formed the basis for the ORBIT II pivotal trial. This three-year feasibility data shows that using CSI’s technology to treat calcified coronary arteries before stenting achieved not only early procedural success but also positive long-term outcomes.
“This case series demonstrates that CSI’s system can safely modify calcified lesions and facilitate stent delivery in this subset of difficult-to-treat patients,” said presenter Stevan Himmelstein, M.D., Baptist Memorial Hospital-Desoto, Memphis, Tenn. “Coronary artery disease, or CAD, is the leading cause of death for men and women in the United States. To have a potential solution for this pressing problem is encouraging.”
It is estimated that moderate to severe arterial calcium is present in nearly 40 percent of patients treated with interventional therapies. Calcium can lead to poor outcomes and higher treatment costs in coronary intervention when traditional therapies are used, including a significantly higher occurrence of death and major adverse coronary events.
The ORBIT I study consisted of 50 patients enrolled at two sites in India from May to June 2008. All subjects had at least one calcified coronary lesion with stenosis between 50 and 100 percent. Thirty-three of the 50 patients were enrolled at one of the two sites and were followed for three years post-procedure. The evaluated safety endpoint was major adverse cardiac event (MACE) rates.
Results show:
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In hospital |
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1 month post |
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6 months post |
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2 years post |
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3 years post |
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% |
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procedure |
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procedure |
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procedure |
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procedure |
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% |
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% |
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% |
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% |
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Overall MACE |
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6.1 |
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9.1 |
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12.1 |
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15.2 |
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18.2 |
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Cardiac death |
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0 |
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0 |
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3.0 |
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6.1 |
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9.1 |
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Non Q-Wave MI |
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6.1 |
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9.1 |
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9.1* |
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9.1 |
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9.1 |
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Q-Wave MI |
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0 |
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0 |
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0 |
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0 |
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0 |
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TLR |
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0 |
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3.0 |
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3.0* |
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3.0 |
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3.0 |
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* One non Q-wave MI at 30 days that led to TLR |
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David L. Martin, CSI president and CEO, said, “Based on the results from our ORBIT I clinical study, demonstrating the safety in treating severely calcified coronary lesions, our orbital platform technology may be well suited for the removal of calcified plaque in coronary arteries. Our pivotal 443-patient ORBIT II PMA [premarket approval] clinical study has recently concluded and we are nearing completion of an FDA [U.S. Food and Drug Administration] submission to secure a coronary indication for our technology.”
CSI completed enrollment in the ORBIT II trial in November 2012. ORBIT II is CSI’s pivotal coronary IDE (investigational device exemption) trial studying this subset of patients. CSI is targeting the end of the quarter to submit its PMA package to the FDA.
For more information: www.csi360.com
April 24, 2024 
