Morph AccessPro Steerable Introducer
The Morph AccessPro steerable introducer (BioCardia, San Carlos, CA) was developed to simplify procedures associated with peripheral artery disease (PAD), enhance physician control, and thereby help improve clinical outcomes. The Morph AccessPro system is an arterial-access steerable conduit with a profile small enough to be used in routine PAD procedures and an inner lumen large enough to deliver the equipment used in treating PAD such as stents, atherectomy devices, laser systems, and balloons.

For PAD procedures, the AccessPro system is designed to act as a steerable introducer, guide, and interventional sheath. It has potential to enable the first steps in a standard limb access procedure to be performed more quickly with less equipment. The AccessPro system is intended to be shaped in real time by the physician to conform more closely to the patient anatomy during the procedure and to provide greater backup support than standard fixed guides and sheaths. This device includes a soft dilator, a smooth transition from dilator to catheter tip, and a trackable and kinkresistant hybrid catheter shaft intended to optimize flexibility and torque transmission, the company stated.

Bengal Radial Compression Band
AccessClosure, Inc. (Mountain View, CA) recently announced an exclusive distribution agreement for the Bengal radial compression band in the United States. The Bengal, uniquely designed for transradial procedures, will join the Mynx Vascular Closure Device in AccessClosure's portfolio of products. The Bengal design offers a new approach to radial artery closure, combining a compression pad that delivers a unique pattern of targeted pressure with a soft polymer gel that ensures patient comfort while the band is on the wrist, the company stated. The simple yet elegant design optimizes targeted compression and allows for maximum manual control and feedback through deployment, adjustment, and removal of the band. Designed in partnership with radial pioneer Olivier F. Bertrand, MD, PhD, FSCAI, an interventional cardiologist at the Quebec Heart-Lung Institute and Associate Professor, Faculty of Medicine, at Laval University, the Bengal is a simple tool that achieves effective hemostasis while protecting the ulnar nerve and providing a comfortable experience for the patient. The extended surface area of the compression pad combined with the ease of adjustability allow the user to achieve patent hemostasis and provide for protection of the radial artery.

Ovation Abdominal Stent Graft System
TriVascular, Inc. (Santa Rosa, CA) announced that it has received CE Mark approval for the Ovation abdominal stent graft. The 14-F outer diameter (OD) system offers the lowest profile of any commercially available device and is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomies.

“The Ovation system is a novel technology that optimizes the two most important requirements for EVAR; fixation and seal,” said Michael Dake, MD, Professor of Cardiothoracic Surgery at Stanford University School of Medicine. “Across a broad cohort of patients, the clinical results are very compelling.”

The Ovation abdominal stent graft system has been implanted in approximately 50 patients across three continents. “CE Mark approval for Ovation is a huge milestone for our organization,” said Michael Chobotov, PhD, President and CEO of TriVascular, Inc. “As we invest in our international team, what excites me most is the prospect of bringing advanced technology to physicians and patients.”

Gore C3 Delivery System
W. L. Gore & Associates (Flagstaff, AZ) announced the first clinical uses of the Gore C3 delivery system to deploy the Gore Excluder AAA endoprosthesis. The Gore C3 delivery system provides physicians with a proven stent-graft that now offers delivery options that they never had before. The Gore Excluder device remains virtually unchanged, maintaining the same low delivery profile and flexibility on catheter that facilitates access and passage through narrow and tortuous anatomies. Once delivered into the aorta, the Gore C3 delivery system uniquely and intuitively enables repositioning of the stent-graft during the procedure. The ability to reposition the device may minimize complications that could occur were the graft to be positioned incorrectly during the initial deployment. This next-generation technology was designed to give physicians a second or third opportunity to accurately place the stent-graft relative to the patient's anatomy.

Eric Verhoeven, MD, who performed the first procedure with the Gore C3 delivery system, commented, “Overall, the Gore C3 delivery system worked as it was designed and provided unparalleled control while remaining intuitive and easy to use.” Additional subsequent procedures have been performed at multiple centers throughout Europe.