Coaptite™

Injectable Implant

For effectiveness, durability and ease of use... it’s a natural

Coaptite Injectable Implant is designed to offer improved procedural ease of use, fewer re-injections, and less material volume versus another approved bulking agent while maintaining the durability characteristics of a synthetic product.

COMMI T MEN T TO CL INICA LBoston Scientific is committed to providing products that meet the clinical standards of the physician community.

The combination of calcium hydroxylapatite (CaHA) particles and the sodium carboxymethylcellulose (NaCMC) carrier gel form a scaffold

that promotes tissue infiltration. The Coaptite Implant particles are composed of the same components that are found in bone and

teeth, and are biocompatible.

Less Material Volume• Coaptite Implant patients required 37% less material

volume upon first injection. In total injections, Coaptite Implant patients required 41% less material volume during the PMA clinical trial (Fig 2).

• Less material volume means fewer syringe exchanges potentially reducing the risk of needle movement during injections and less time in the procedure.

• Less material volume injected reduces cost to the facility and to the patient.

Ease of Use• A 21 gauge needle is designed to reduce product

extravasation and surrounding tissue trauma.

• No refrigeration storage is required for the Coaptite Implant.

• No skin test is required.64626058565452

Coaptite

Injectable ImplantBovine

Dermal Collagen

% o

f Pat

ient

s

6866

1 year1 2 year2 1 year3 2 year4

PMA Clinical Trial, Stamey Grade Improvement

63.4%

66.7%

57.0%

Fig. 1

67

543210

p<0.0001

Volu

me

(mls

)

Coaptite®

Injectable Implant

n=60

Bovine Dermal

Collagenn=36

Coaptite®

Injectable Implant

n=98

Bovine Dermal

Collagenn=102

SINGLE INJECTION TOTAL INJECTIONS

2.15

4.0

6.8

3.39

Average Injection Volumes,PMA Clinical Trial

Fig. 2

PMA Clinical Trial. Data on file at Merz Aesthetics, Inc. Results from case studies are not predictive of results in other cases. Results in other cases may vary.

Picrosirius Red Staining for Collagen (Fig. 3)The Coaptite Implant promotes tissue ingrowth in the urethra.

Note absence of red stain around particles which indicates lack of new collagen infiltration.

CaHA particles

4-week section of a canine model

Note presence of red stain around particles which indicates new collagen infiltration.*

New collagen infiltration

16-week section of a canine model

Coaptite Implant Over 250,000

syringes injected

Ef fectiveness and Durability

*Bench tests results may not be indicative of clinical performance.

1 n=83 patients out of a total 131 patients who had 12 month follow-up2 n=26 patients out of a total 39 patients who had 24 month follow-up3 n=57 patients out of a total 100 patients who had 12 month follow up4 24 month data not available for Bovine Dermal Collagen patients

Procedural Steps

➤ The objective of the Coaptite Injectable Implant procedure is to obtain closure at the bladder neck to mid-urethra by injecting the Coaptite Implant until the tissue of the bladder neck and/or urethra coapts.

➤ Using standard procedure, prepare the patient for cystoscopy. Connect the Coaptite Implant syringe to the needle by turning the needle hub 1-1/2 turns ensuring that one green dot on the syringe is visible through the window on the needle hub. Prime the needle.

➤ Insert the primed needle into the port of the scope. Insert the scope into the urethra.

1 2 3 4

➤ At the mid urethra, position the needle bevel towards the urethral lumen at a 4 o’clock position.

➤ Puncture the tissue at a 45˚ angle until the bevel of the needle is covered in tissue. Do not insert past the bevel.

➤ Re-angle the scope back parallel to the urethra. Using the circumferential markings on the needle as a guide, tunnel the needle tip towards the bladder neck depending on the approximated length between the mid-urethra and bladder neck. After tunneling, the needle tip should lie at the proximal urethra.

➤ Begin injecting Coaptite Implant using slow, consistent, and moderate thumb pressure on the syringe plunger. The submucosal lining should begin to rise at the site of injection and should flow unilaterally. Continue to inject Coaptite Implant into this site until the bleb has crossed the midline of the urethra.

➤ Repeat steps 2–6 on the contralateral side at the eight o’clock position.

5 6 7 8

➤ The objective of the procedure is to obtain closure at the bladder neck to mid-urethra. Continue to inject Coaptite Implant until the tissue of the bladder neck and/or urethra coapts. The bladder neck/ urethra should be closed when viewed with cystoscopic irrigation on.

➤ The combination of Coaptite (CaHA) Implant and the carrier gel Sodium Caboxymethylcellulose (NaCMC) help to establish an even distribution of particles with a degree of interstitial space that promotes collagen infiltration. The carrier gel is gradually absorbed and replaced by the surrounding cells.

Coaptite™ Injectable Implant

All images are owned by Boston Scientific.

All trademarks are the property of their respective owners.

Refer to Coaptite Injectable Implant Instructions for Use provided with product for complete instructions for use.

INDICATIONS: Coaptite Injectable Implant is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult females. CONTRAINDICATIONS: The Coaptite Injectable Implant is contraindicated for use in a patient: who has significant history of urinary tract infections without resolution; who has current or acute conditions of cystitis or urethritis; who has fragile urethral mucosal lining. POTENTIAL ADVERSE EFFECTS that may occur include: genitourinary adverse events (i.e., urinary retention, hematuria, dysuria, UTI, urinary urgency and frequency), erosion, erythema, embolic phenomena, and vas-cular occlusion. WARNINGS: Note: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury. WARNING: Following injection of Coaptite Implant, dissection of the device through tissue may lead to 1) tissue erosion and may require corrective surgery or 2) elevation of the bladder wall causing ureteral obstruction. This may be caused by improper injection technique using Coaptite Implant. (See adverse event section in IFU for further information.) WARNING: Women with peripheral vascular disease and prior pelvic surgery may be at increased risk for tissue erosion following injection of Coaptite Implant. (See adverse event section in IFU for further information.) Please refer to complete instructions for use for a complete listing of all warnings and potential adverse effects. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in diagnostic and therapeutic cystoscopy.

Legal Manufacturer:Merz Aesthetics, Inc.4133 Courtney Road Suite 10Franksville, WI 53126

ORDERING INFORMATION

Product Code Description

M0068903000 Coaptite™ Injectable Implant, 1 ml syringe each

M0068903040 Sidekick™ Needle, 14.6 inch, 21 ga.

Boston Scientific Corporation300 Boston Scientific Way Marlborough, MA 01752www.pelvic-floor-institute.com

Ordering Information 1.888.272.1001

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

WH-413615-AA SEP 2016