Polaris Software

Boston Scientific Corporation
(508) 650-8000
www.bostonscientific.com

KEY FEATURES
• Fast: Power on and go
• Easy: One-click access to most features
• Accurate: Improved TraceAssist

Boston Scientific Corporation has launched the new Polaris software for use on its iLab imaging system, which has received CE Mark approval and US Food and Drug Administration 510(k) clearance. The system will support the company's family of intravascular ultrasound catheters, including coronary, peripheral, and intracardiac echo products. Its modular design will support the planned release of new imaging products, including a fractional flow reserve wire, new intravascular ultrasound catheters, enhanced software features, and better system control tools.

In Boston Scientific's press release, Lowell Satler, MD, commented, “The Polaris system is an advance for intravascular imaging. The improved ease of use and image processing simplifies the procedure and enables our team to quickly obtain the information needed to treat patients.” Dr. Satler is Director of Coronary Interventions at MedStar Washington Hospital Center in Washington, DC.

Adelante Magnum Hemostatic Valve Introducer

Oscor Inc.
(727) 937-2511
www.oscor.com

KEY FEATURES
•Multilayer, hydrophilic-coated sheath
• Specially-designed distal tip portion
• SureSeal technology
• Available in multiple French sizes and sheath lengths

Oscor Inc. has received FDA 510(k) clearance for the Adelante Magnum hemostatic valve introducer for large-size vascular access. The device is specifically designed and optimized for the introduction and placement of endovascular catheters, aortic valves, and stent graft systems. The proprietary multilayer, hydrophilic-coated sheath has a specially designed distal tip portion to accept and tolerate the insertion and manipulation of large and complex devices. Adelante Magnum's SureSeal technology facilitates hemostasis, allowing the insertion of multiple catheters and wires simultaneously with minimal blood loss.

NC Euphora Coronary Balloon

Medtronic, Inc.
(763) 514-4000
www.medtronicendovascular.com

KEY FEATURES
• PowerTrac technology
• Optimized tapered tip design
• High pressure capability (up to 20 atm)
• Low growth profile
• Enhanced packaging

Medtronic, Inc. has received US Food and Drug Administration 510(k) clearance for the NC Euphora noncompliant balloon dilatation catheter. The device includes the company's PowerTrac technology, requiring less force to track through tortuous anatomy for deliverability through challenging lesions. An optimized tapered tip design and low lesion entry profile improve flexibility and allow for reliable stent recross. Low radial growth reduces unwanted vessel expansion, and low longitudinal growth beyond the stent length minimizes damage to the surrounding healthy artery.

“When developing NC Euphora, insights from the entire cath lab team were gathered and addressed to ensure it meets the current needs of cath lab professionals in device design and performance,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, Georgia.

CoreValve Evolut R System

Medtronic, Inc.
(763) 514-4000
www.medtronicendovascular.com

KEY FEATURES
• 23-mm self-expanding valve
• 14-F–equivalent delivery system
• Enables recapture and repositioning during deployment
• Low-profile InLine sheath

Medtronic, Inc. has received CE Mark approval for the 23-mm CoreValve Evolut R transcatheter aortic valve replacement system. The self-expanding valve and 14-F–equivalent delivery system offer new capabilities for valve performance and deliverability during the procedure while providing the option to recapture and reposition the valve during deployment. The valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing while maintaining supra-annular valve position for improved hemodynamic performance.

“The system's new recapture-enabled capabilities and advancements in valve delivery provide physicians with added procedural confidence. It's a significant advance to know there is the option to redeploy the valve in the ideal position if necessary,” commented Eberhard Grube, MD, head of the Center of Innovative Interventions in Cardiology, University Hospital Bonn in Bonn, Germany, in the company's press release.