Feature | May 29, 2013

Cardiovascular Systems Presents New Coronary Results

Orbital atherectomy trial shows 92.8 percent freedom from severe complications at 30 days.

May 29, 2013 — Cardiovascular Systems Inc. (CSI) has presented 30-day results from its ORBIT II clinical study of coronary artery disease.

ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. This is the first Investigational Device Exemption study to evaluate this problematic subset of patients. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012 and submitted its Premarket Approval application to the U.S. Food and Drug Administration (FDA) on March 15, 2013.

Jeffrey Chambers, M.D., of Metropolitan Heart and Vascular Institute, Minneapolis, Minn., highlighted new data showing that 92.8 percent of patients were free from severe angiographic complications at 30 days. Additionally, core lab assessed final procedure residual stenosis was 4.7 percent.

“Patients who suffer from severely calcified coronary lesions are one of the toughest-to-treat populations, and 30-day ORBIT II results demonstrate that CSI’s orbital atherectomy technology may be a practical treatment option,” Chambers said. “Patients with moderate-to-severe calcium are more likely to experience major adverse coronary events (MACE), or even death. To have a potential solution for this problem is exciting.”

Chambers said 30-day data showed the ORBIT II trial met primary endpoints treating patient population in which 99.3 percent of subjects had severely calcified lesions. The 30-day freedom from MACE rate was 89.8 percent and the procedural success of 89.1 percent (including in-hospital MACE).

For more information: www.csi360.com

Related Content

warfarin, atrial fibrillation, kidney failure, HRS 2016
News | Antiplatelet and Anticoagulation Therapies| May 06, 2016
Atrial fibrillation patients taking warfarin are at higher risk of developing kidney failure if anticoagulation levels...
SCAI 2016, PCI, bleeding risk, bivalirudin, NCDR risk calculator, clinical trial
News | Antiplatelet and Anticoagulation Therapies| May 06, 2016
The largest risk-directed study by a national hospital system demonstrates a 40 percent decline in bleeding events for...
News | Cardio-oncology| May 06, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI) has released an expert consensus statement...
CSI, Cardiovascular Systems Inc, Diamondback 360 Coronary Orbital Atherectomy System, OAS, ORBIT II study, three-year results, SCAI 2016
News | Atherectomy Devices| May 06, 2016
May 6, 2016 — Cardiovascular Systems Inc.
TOBA-BTK study, twelve-month results, SCAI 2016, Tack Endovascular System, critical limb ischemia
News | Peripheral Arterial Disease (PAD)| May 05, 2016
Intact Vascular Inc. announced that positive twelve-month results from its Tack Optimized Balloon Angioplasty – Below-...
SCAI, cath lab, best practices, guidelines, 2016
News | Cath Lab| May 05, 2016
May 5, 2016 — The Society for Cardiovascular Angiography and Interventions (SCAI) published an update to its 2012 pap
FDA, CDRH, national evaluation system, medical device development
Feature | Business| May 04, 2016
The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to...
radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
microtubules, heartbeat mechanics, Perelman School of Medicine study

Microtubules in a cardiomyocyte at rest (top) and when compressed. Image courtesy of the lab of Ben Prosser, Ph.D., Perelman School of Medicine, University of Pennsylvania

News | EP Lab| April 29, 2016
Using new high-resolution microscopy, researchers have found that molecular struts called microtubules (MT) interact...
breast cancer, herceptin chemotherapy drug, heart damage, monitoring, Journal of Clinical Oncology study
News | Cardiac Diagnostics| April 28, 2016
April 28, 2016 — Breast cancer patients undergoing treatment with trastuzumab-containing regimens should be monitored
Overlay Init