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Products

CapSure™ Permanent Fixation System

Permanent Fixation Redefined

Overview
Products & Accessories
EIFU & Resources
FAQ

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Traditional challenges in permanent fixation for hernia repair

Permanent fixation devices facilitate a strong long-term repair but may be associated with some challenges:

Clinical complications from exposed metal points including adhesions to fastener
Difficulties securing large pore mesh may impact hernia repair outcomes
Deployment challenges and device reliability issues can disrupt procedures

Bard has redefined permanent fixation

Covered

Smooth polyetheretherketone (PEEK) cap eliminates exposed metal tip and helps minimize adhesions to the fastener^*

Strong

Fixates into Cooper’s ligament and underlying structures, similar to ProTack™

Reliable

Comfortable handle and easy to deploy trigger
Consistent fastener deployment and depth of tissue purchase
Reliable, secure fixation regardless of mesh pore size
Improved fixation with large pore meshes due to larger cap surface area of fastener versus ProTack™

^{*Preclinical data. Results may not correlate to the performance in humans}

REDEFINED FASTENER DESIGN

316L stainless steel

316L stainless steel is a surgical stainless steel commonly used in biomedical implants that are put under pressure including bone screws and prostheses

Smooth PEEK cap

Cap is made from polyetheretherketone (PEEK). PEEK is an inert organic thermoplastic polymer, considered an advanced biomaterial

PEEK is used in many medical implants including dental implants, heart valves and stents, and joint prostheses

DESIGNED FOR OPTIMIZED CLINICAL BENEFITS

A 90 Day Preclinical Adhesion Study Demonstrated Stronger Results with the CapSure™ Fixation System vs. ProTack™ Fixation System.

Evaluation of a Novel Permanent Capped Helical Coil Fastener in a Porcine Model of Laparoscopic Ventral Hernia Repair

^{Arnab Majumder, Mojtaba Fayezizadeh, William W. Hope,}Yuri W. Novitsky • Surgical Endoscopy April 2016

Significantly less adhesion coverage
Greater percentage of properly engaged fasteners
Greater mesh/tissue integration
Shielding exposed fastener points on the visceral mesh surface with polymer caps is suggested by the data to reduce adhesion formation and aid in mesh fixation and integration

^{_{Preclinical data. Results may not correlate to performance in humans.}}

STRONG REPAIR

CapSure™ fastener easily penetrates Cooper’s ligament and underlyingstructures, equivalent to ProTack™

Equivalent Strength to ProTack™ at t₀, Greater Strength Over Time

Burst strength testing demonstrated that in a porcine model CapSure™ fixated Ventralight™ ST Mesh had a greater (4.3%) burst strength at t₀ and significantly higher (18.4%) peak burst strength at 6 weeks post-implantation than did ProTack™ fixated Ventralight™ ST Mesh at the same time point (p = .0088).

^{* Porcine abdominal wall tissue:

Animal data may not correlate to performance in humans}

^{* Porcine 6 week implant study:

Animal data may not correlate to performance in humans}

Reliable

Better confidence in your delivery system performance

Rotary drive system with a comfortable handle and easy to deploy trigger, with an average delivery force that is 30% less than ProTack™¹
Consistent fastener deployment and depth of tissue purchase – preclinical studies demonstrated more favorable fastener seating results versus ProTack™²
Available in 15 and 30 fastener count devices providing significant savings per device over ProTack™, for repairs where 15 or less fasteners are required

CapSure™ Fasteners

CapSure™ Fasteners have 2X the mesh surface area coverage to hold mesh in place ensuring secure fixation and more visible fasteners. Bench testing with 3DMax™ Light demonstrates that CapSure™ is 15X more likely to retain large pore mesh versus ProTack™¹

1. Bench top data. Results many not correlate to performance in humans.

2 Preclinical data. Results may not correlate to performance in humans

Indications

The CapSure™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Contraindications

Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera. Use of the CapSure™ Permanent Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is another 1 mm (total 4.2 mm).

Precautions

Adequate counter pressure should be applied on the target area. Avoid placing hand or finger directly over the area where fastener is being deployed to prevent injury. Use caution when applying the CapSure™ fastener over or in proximity to underlying bone, vessels, nerves, or viscera. The intended fixation site should be assessed to ensure that while the tissue is compressed the total distance from the surface of the tissue to any underlying structures is greater than the length of the CapSure™ fastener. Adverse Reactions

Adverse reactions and potential complications associated with fixation devices such as the CapSure™ Permanent Fixation System may include, but are not limited to the following: hemorrhage, pain, edema and erythema at wound site; septicemia/infection; hernia recurrence/wound dehiscence, erosion and allergic response in patients with known sensitivities to PEEK and metals contained in 316L stainless steel, including chromium, nickel, copper, and iron.

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BD-14700