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

This study looked at the effects of long periods of apnea on the heart. Cardiac MRI showing normal left ventricular function in the standard horizontal long axis (upper two images) and with corresponding short axis (lower two images) in diastole (left) and systole (right), at the mid ventricular section of the heart (white line).

News | Magnetic Resonance Imaging (MRI)| December 01, 2015
December 1, 2015 — Athletes who engage in the extreme sport of free diving, descending hundreds of feet below the sur
coherex Wave Crest LAA Occluder

Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

News | November 24, 2015
November 24, 2015 — Biosense Webster announced it has acquired Coherex Medical Inc., a privately held medical device
Feature | Cath Lab| November 24, 2015
November 24, 2015 — The U.S.
News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

Image courtesy of Boston Scientific

News | Left Atrial Appendage (LAA) Occluders| November 20, 2015
Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device
protein reprogramming, Stem Cells Translational Medicine, cardiac progenitor cells, CPCs, regenerative therapies
News | Stem Cell Therapies| November 13, 2015
A new study appearing in STEM CELLS Translational Medicine (SCTM) describes a highly efficient, protein-based method...
angina, abnormal heart blood flow, female-pattern heart disease, Cedars-Sinai Heart Institute study, AHA Scientific Sessions
News | Cardiac Diagnostics| November 13, 2015
Chest pain in female-pattern heart disease is linked with abnormal heart blood flow, a new Cedars-Sinai Heart Institute...
News | Antiplatelet and Anticoagulation Therapies| November 12, 2015
Preventing blood clots with drugs such as heparin has become a common practice for fighting some heart and lung...
pharmacist-physician collaboration, high blood pressure control, minority and low-income populations
News | Hypertension| November 12, 2015
November 12, 2015 — A pharmacist-physician collaborative effort to control blood pressure among a diverse group of pa
Overlay Init