Coaptite - Boston Scientific

1 Coaptite Injectable ImplantFor effectiveness, durability and ease of it s a naturalCoaptite 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 TO CLINICALB oston Scientific is committed to providing products that meet the clinical standards of the physician 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).

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 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 Injectable ImplantBovine Dermal Collagen% of Patients68661 year1 2 year21 year3 2 year4 PMA Clinical Trial, Stamey Grade 167543210p< (mls) Coaptite Injectable Implantn=60 Bovine Dermal Collagenn=36 Coaptite Injectable Implantn=98 Bovine Dermal Collagenn=102 SINGLE INJECTIONTOTAL Injection Volumes,PMA Clinical TrialFig. 2 PMA Clinical Trial. Data on file at Merz Aesthetics, Inc. Results from case studies are not predictive of results in other cases.

3 Results in other cases may vary. Picrosirius Red Staining for Collagen (Fig. 3)The Coaptite Implant promotes tissue ingrowth in the absence of red stain around particles which indicates lack of new collagen particles4-week section of a canine model Note presence of red stain around particles which indicates new collagen infiltration.*New collagen infiltration16-week section of a canine model Coaptite Implant Over 250,000 syringes injectedEffectiveness and Durability*Bench tests results may not be indicative of clinical 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 patientsProcedural 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.

4 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 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.

5 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. 5678 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.

6 The carrier gel is gradually absorbed and replaced by the surrounding cells. Coaptite Injectable ImplantAll images are owned by Boston trademarks are the property of their respective to Coaptite Injectable Implant Instructions for Use provided with product for complete instructions for : 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 ( , urinary retention, hematuria, dysuria, UTI, urinary urgency and frequency), erosion, erythema, embolic phenomena, and vas-cular occlusion.

7 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 Manufacturer:Merz Aesthetics, Courtney Road Suite 10 Franksville, WI 53126 ORDERING INFORMATIONP roduct Code DescriptionM0068903000 Coaptite Injectable Implant, 1 ml syringe eachM0068903040 Sidekick Needle, inch, 21 Scientific Corporation300 Boston Scientific Way Marlborough, MA Information 2016 Boston Scientific Corporation or its affiliates.

8 All rights SEP 2016