ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the first patients in the United States were treated using the OrbusNeich® Teleport Microcatheter (Teleport), which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Microcatheters are used to provide support and safe guidewire exchange during complex cardiovascular procedures. Teleport is a new generation microcatheter designed for deliverability and support, with a unique and robust tip designed to enable access in the most challenging lesions.
Annapoorna S. Kini MD, Director of the Cardiac Catheterization Laboratory at Mount Sinai Medical Center, New York, NY, and Emmanouil Brilakis, MD, PhD, FACC, FAHA, FESC, FSCAI, Interventional Cardiologist at Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN, treated the first patients in the United States with Teleport.
Said Dr. Kini, “I am excited and honored to be the first to use Teleport microcatheter in the United States. Teleport allowed me to deliver the microcatheter easily through tortuous coronary vasculature while maintaining catheter position for guidewire exchange treating a complex chronic total occlusion.”
Dr. Brilakis, added, “I had the opportunity to use the Teleport Microcatheter in Europe and was impressed by its balance of deliverability and support. Teleport’s robust tip design is unique, enabling access to tight lesions while providing the torqueability necessary to treat very challenging lesions. I’m excited to have this device available to treat my patients here in the United States.”
Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We are committed to building a comprehensive cardiovascular company and leveraging our commercial footprint and clinical value to become the partner of choice in the revascularization of patients with complex peripheral and coronary artery disease. The clearance of the Teleport Microcatheter complements our emphasis on providing advanced solutions for the most difficult coronary and peripheral lesions.”
OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world's first dual therapy stents, the COMBO Plus and COMBO Dual Therapy Stents, together with stents and balloons marketed under the names of Azule®, Scoreflex®, Sapphire® II, Sapphire® II PRO and Sapphire® II NC, as well as products to treat peripheral artery disease: the Jade® and Scoreflex® PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries. For more information, visit www.OrbusNeich.com.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s OAS treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over 400,000 of CSI’s devices have been sold to leading institutions worldwide.
Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding CSI’s plans to build a comprehensive cardiovascular company and become the partner of choice in the revascularization of patients with complex peripheral and coronary artery disease; the benefits of the Teleport Microcatheter; and the commercial launch of the Teleport Microcatheter in the U.S., are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, agreements with third parties to sell their products; the experience of physicians regarding the effectiveness and reliability of products sold by CSI, including the Teleport Microcatheter; the reluctance of physicians, hospitals and other organizations to accept new products; the impact of competitive products and pricing; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.
U.S. Indications for Use
The Teleport microcatheters are indicated for:
- Supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature
- Exchanging guidewires in the coronary and peripheral vasculature
- The delivery of contrast media into the coronary, peripheral and abdominal vasculature