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OPTEASE

OPTEASE
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OPTEASE

Product catalog summary
Product Overview
The OPTEASE™ Retrievable Vena Cava Filter is designed for both temporary and permanent use, offering flexibility in patient care. It can be removed up to 12 days post-implantation and is engineered to minimize risks associated with retrievable filters.

Design Features
  • Low Profile Delivery System: Utilizes a 6F delivery system with six potential access points, providing versatility in placement.
  • Closed Cage Design: Aims to prevent caval perforation and strut embolization, reducing the risk of complications.
  • Fixation Barbs: Designed to minimize migration and maintain clot capture efficiency.
  • Dual Prong Caudal Hook: Facilitates easier snare capture for retrieval.
  • Side Struts: Self-centering upon insertion to reduce tilting and enhance stability.

FDA Safety Communication
In 2014, the FDA highlighted concerns about adverse events with vena cava filters, including filter embolization, IVC penetration, and filter migration. The OPTEASE™ filter addresses these issues with a design that supports safe retrieval and low complication rates.

Clinical Evidence
The PROOF study demonstrated the safety and efficacy of the OPTEASE™ filter, with fewer than 1% of patients experiencing migration or new thrombus formation. The study reported no cases of symptomatic pulmonary embolism, caval perforation, or strut embolization.

Ordering Information
The OPTEASE™ filter is available in various configurations for femoral, jugular, and antecubital access, with specific catalog numbers provided for each option.

Warnings
Improper implantation orientation can lead to serious complications, including vessel perforation and ineffective embolism prevention. Healthcare professionals should refer to the device's instructions for detailed guidance.
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Catalog excerpts

OPTEASE-1

Retrievable & PermanentA B L E PROVEN & RELI Retrievable Vena Cava Filter

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OPTEASE-2

Product Overview Retrievable Vena Cava Filter Leave It In. Take It Out. Your Choice. Our Advantage. Safe Profile • ow profile, 6F delivery system L • emoval is optional for up to 12 days R • ix potential access points S • obust design for long term durability R • D emonstrated low complication rates across multiple clinical studies • esign helps reduce risks known to D retrievable filters • P ROOF results demonstrate low rate of

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OPTEASE-3

FDA Recommendations for Retrieval Shorter Retrieval Window FDA Recommendation1: Between 1 and 2 months the risk-benefit profile favors removal of the filter if the patient's transient risk for PE has passed. The Problem: In 2014, the FDA issued a Safety Communication highlighting concern about adverse events reported with vena cava filters, noting that some complications may The Cordis Solution: The Cordis OPTEASE™ Retrievable Vena Cava Filter can be removed up to 12 days from the date of implantation and is proven to have low complication rates. Cordis uPTeasi Retrievable Vena Cava Filter LOW...

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OPTEASE-4

Designed to Deliver Performance and Stability for Every Patient Six Insertion Sites For ease of use Fixation Barbs including femoral, Minimize migration veins bilaterally capture efficiency Closed Cage Designed to eliminate risk of caval perforation and strut embolization Eliminates risk of arm entanglement Side Struts Self centering upon insertion reduces the risk of tilting Dual Prong Caudal Hook For easier snare capture

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OPTEASE-5

Design Specifications Fixation Barbs • Minimize risk of migration to maintain clot capture efficiency • "Ski Barb" design resists cranial migration which can lead to serious complications • Location at upper pole allows for earlier wall apposition when placed via femoral access Back to Performance Page

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OPTEASE-6

Design Specifications • Dual prong hook designed for easier snare capture • Femoral retrieval route avoids passing through the heart • 12 day retrieval Back to Performance Page

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OPTEASE-7

Design Specifications Side Struts • Self centering upon insertion, reducing the risk of tilting which can decrease clot capture efficiency • Dual Prong Caudal Hook for easier capture with any appropriate endovascular snare • Minimize risk of migration providing caval wall contact earlier in the deployment process than other designs Back to Performance Page

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OPTEASE-8

Design Specifications Closed Cage Design Fully connected structure designed to eliminate the risk of caval perforation by needle-like arms Designed to eliminate strut embolization after fracture of a single strut segment Eliminates risk of struts becoming entangled, thereby leaving a gap between struts Back to Performance Page

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OPTEASE-9

Here’s the PROOF Study results : A Demonstration of Safety that Results in Confidence In the prospective, multi-center, single filter, trial with 150 patients at 11 U.S. sites, the OPTEASE Vena Cava Filter had no reports of symptomatic PE, caval perforation or strut embolization1. ™ Symptomatic PE Caval Penetration Strut Embolization Results from this study show that the OPTEASE Retrievable Vena Cava Filter can be safely used as a permanent filter in patients at high risk for pulmonary embolism. ™ Fewer than 1% of patients experienced filter migration or new thrombus formation with the OPTEASE...

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OPTEASE-10

Clinical Studies One of The Most Tested Filter on The Market OPTEASE Retrievable Vena Cava Filter PROOF Trial: Protection from Pulmonary Embolism with the Cordis OPTEASE Retrievable Vena Cava Filter1 ™ Click Here for PROOF Publicatio

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OPTEASE-11

OPTEASE™ Retrievable Vena Cava Filter Cordis OPTEASE™ Retrievable Vena Cava Filter Ordering Information Cordis OPTEASE™ Vena Cava Filter and Introduction Kit (55 cm) Femoral 466-F210AF Cordis OPTEASE™ Vena Cava Filter and Introduction Kit (55 cm) Jugular 466-F210AJ Cordis OPTEASE™ Vena Cava Filter and Introduction Kit (90 cm) Antecubital, Jugular 466-F210BJ ’Ziegler, JW et al. PROOF Trial: Protection from Pulmonary Embolism with the OPTEASE™ Filter. JVIR 2008; 19:1165-1170. WARNING: Implant of the OPTEASE™ Vena Cava Filter with the hook oriented in the cranial direction can result in life threatening...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.