Mimics Innovation Suite of Software and Services

Materialise
(734) 259-6445, ext. 572
www.biomedical.materialise.com.

KEY FEATURES
• Software: medical image processing and analysis
• Intervention planning: digitally position devices and select size
• Clinical trial services: patient reports and models
• HeartPrint: 3D-printed anatomical and benchtop models

The Mimics Innovation Suite, developed by Materialise, was recently released in a new version with US Food and Drug Administration clearance and CE Mark approval. The Mimics toolbox increases the utility of 3D imaging data (CT, MRI, and 3D ultrasound). This toolbox may be used to understand the geometry and dynamics of cardiac anatomy, virtually plan and visualize proposed interventions, 3D print physical replicas of the patient’s anatomy, and link to computational modeling methods (finite element analysis and computational fluid dynamics). Added to the latest version are new measurement functionality for transcatheter valve sizing and tools to create a simpler link to 3D-printed models. This tool is intended for interventionists who are designing, verifying, or validating their innovations and wish to use reliable image segmentation and accurate 3D reconstructions to evaluate whether they are appropriate for their intended use.

Agent Paclitaxel-Coated PTCA Balloon Catheter

Boston Scientific Corporation
(888) 272-1001
www.bostonscientific-international.com.

KEY FEATURES
• Proprietary TransPax efficient coating technology
• Outstanding deliverability
• Optimized drug transfer
• Enhanced balloon technology

Boston Scientific has received CE Mark approval for the Agent paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter. Agent offers a proprietary coating, TransPax efficient coating technology, which is designed to provide optimized drug transfer and outstanding deliverability. TransPax ensures that a consistent, therapeutic drug dose is delivered to the lesion and optimizes drug transfer to the vessel wall. The enhanced coating durability reduces downstream systemic loss of materials. Agent offers exceptional deliverability thanks to its use of the Emerge PTCA catheter platform, which is designed to navigate challenging lesions. Agent offers an ultra-low tip profile and a Bi-Segment inner shaft designed for a flexible distal segment and pushable proximal segment. Agent is available in 9 diameters, ranging from 2 mm to 4 mm. Agent is not available for sale in the United States.

Rebel Platinum Chromium Coronary Stent System

Boston Scientific Corporation
(888) 272-1001
www.bostonscientific.com/rebel.

KEY FEATURES
• Platinum chromium alloy
• Customized stent architecture
• Enhanced stent delivery system

Boston Scientific Corporation has received FDA approval for the Rebel platinum chromium coronary stent system. The Rebel stent offers an identical stent platform to the Promus Premier drug-eluting stent, without the everolimus drug. The Rebel stent system features excellent visibility, low recoil, radial strength, and fracture resistance while improving axial strength and deliverability. Its enhanced low-profile delivery system also features a shorter, more visible tip; a dual-layer balloon; and a Bi-Segment inner lumen catheter designed to facilitate precise stent delivery across challenging lesions. It has a matrix of 46 sizes, including diameters from 2.25 to 4.5 mm and lengths from 8 to 32 mm, on Monorail and over-the-wire catheter platforms.

Chocolate PTCA Balloon Dilatation Catheter

TriReme Medical, LLC
(888) 553-8555
www.trirememedical.com.

KEY FEATURES
• Unique nitinol-constraining structure
• Balloon segments defined by pillows and grooves
• Increased contact surface area
• Controlled dispersion of force
• Controlled, uniform inflation/deflation

The Chocolate PTCA Balloon Dilatation Catheter is an FDA-approved balloon dilation catheter using a unique design aimed at achieving excellent procedural outcomes without leaving a permanent implant. It is indicated for balloon dilatation of a stenotic portion of the coronary artery or a bypass graft stenosis for the purpose of improving myocardial perfusion.

Chocolate PTCA’s key differentiating feature is a nitinol-constraining structure (CS). As Chocolate PTCA is inflated, the balloon expands beyond the CS, thus creating small balloon segments defined by pillows and grooves. The pillows and grooves increase the contact surface area of the balloon compared to standard balloons without a CS. The design is intended to disperse the force associated with angioplasty.

The CS on the balloon facilitates controlled, uniform inflation (thus minimizing “dog boning”); controlled, uniform and rapid deflation; and dispersal of forces along an increased contact surface area. Chocolate PTCA has the same principle of operation and mechanism of action as Chocolate PTA.