News | June 12, 2014

Cardiovascular Systems Enrolls First Patient in Study of New Atherectomy System

Study to assess safety and efficacy of new coronary micro crown

June 12, 2014 — Cardiovascular Systems Inc. (CSI) announced that the first patient has been enrolled in its Coronary Orbital Atherectomy System Trial (COAST) clinical trial. Taking place in the United States and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI’s new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease (CAD). Arthur Lee, North Florida Regional Medical Center, Gainesville, Fla., performed the first procedure.

The micro crown is CSI’s second-generation system designed to facilitate stent delivery in subjects with CAD who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting. The micro crown OAS is designed to improve the tracking and piloting of the OAS driveshaft and the ability of the crown to reach the lesion while operating at low rotational speeds.

“During my first procedure using CSI’s new micro crown OAS, I modified a calcified lesion allowing stent delivery and expansion,” said Lee. “I’m encouraged by CSI's commitment to advancing and improving the technology by expeditiously releasing a second generation of technology in a space that has been stagnant for 25 years.”

Building on CSI’s ORBIT II study, the first study designed to enroll severely calcified lesions that are typically excluded from all major trials but commonly seen in the real world cases, COAST is a prospective, single-arm, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in these difficult to treat lesions.

Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Minimum enrollment is 50 patients in the United States and 25 in Japan. Gregg Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, and Dr. Shigeru Saito, director of cardiology and catheterization laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, are the study’s principal co-investigators.

Stone said: “We’re excited for the potential of CSI’s new micro crown OAS device to provide additional treatment options for heavily calcified lesions seen in the ORBIT II study.”

“We’re eager to launch our first international coronary study which will support the approval of our next-generation system in the United States and Japan,” said David L. Martin, CSI president and chief executive officer. “COAST aligns with our ORBIT II data protocol and study details — giving CSI a further opportunity to build on the compelling results we delivered in ORBIT II. Additionally, it will highlight the potential benefits of our new micro crown and, we hope help secure commercial approval in Japan.”

For more information: www.csi360.com

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init