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

Ambio Health telemonitoring system, LifeBridge Health Cardiovascular Institute, Baltimore, pilot study
News | Remote Monitoring| May 26, 2016
The LifeBridge Health Cardiovascular Institute, Baltimore, has launched a pilot study to evaluate the potential...
Toshiba, Infinix 4-D CT, first U.S. install, Arkansas cancer center
News | CT Angiography (CTA)| May 26, 2016
Cancer patients at the Carti Cancer Center, Conway, Ark., now have access to the latest innovation in diagnostic...
cath lab, radiation exposure, glocoma
Feature | Radiation Dose Management| May 26, 2016 | Dave Fornell
May 27, 2016 — Radiation exposure to cath lab staff and physicians has seen growing concern in recent years, as the p
anticoagulants, U.S. market, Technavio, 2020, trends
News | Antiplatelet and Anticoagulation Therapies| May 25, 2016
Technavio’s latest report on the U.S. anticoagulants market provides an analysis on the most important trends expected...
IVPA, intravascular photoacoustic imaging, fatty arteries, Purdue, Shanghai

IVPA/IVUS imaging of a perfused fresh human right coronary artery dissected from an explanted heart. (A) IVPA image. (B) IVUS image. (C) Merged IVPA/IVUS image. The 1 mm scale bar applies to all panels.

News | Intravascular Imaging| May 25, 2016
A new imaging system known as intravascular photoacoustic (IVPA) imaging that produces three-dimensional images of the...
Edwards, Sapien 3, SOURCE 3 Registry, EuroPCR 2016
News | Heart Valve Technology| May 24, 2016
Thirty-day data from the European post-approval study of the Edwards Sapien 3 transcatheter aortic heart valve...
News | Cath Lab| May 24, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions took place May 4-7, 2016
HeartFlow, FFR-CT, ruptured coronary plaques, EMERALD study, EuroPCR 2016
News | CT Angiography (CTA)| May 23, 2016
First-in-human data presented at EuroPCR 2016 demonstrate that hemodynamic data from HeartFlow Inc. may help predict...
TAVR outcomes, aortic valve gradient, JACC study
News | Heart Valve Technology| May 23, 2016
Patients with a combination of left ventricular dysfunction and low aortic valve gradient have higher mortality rates...
Direct Flow Medical, TAVR device, DISCOVER trial, three-year results, EuroPCR 2016
News | Heart Valve Technology| May 20, 2016
Direct Flow Medical Inc. presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR...
Overlay Init