Urology Events

Reference:

1. Data on file with Boston Scientific.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.

For information purposes only. The content of the referenced articles/publications are under the sole responsibility of the authors/publishers and does not represent the opinion of BSC.

All images are the property of Boston Scientific.

All trademarks are the property of their respective owners.

SpaceOAR™ Hydrogel and SpaceOAR Vue™ Hydrogel 

SpaceOAR and SpaceOAR Vue Hydrogels are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum.

SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue Hydrogel contains iodine.

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.

As with any medical treatment, there are some risks involved with the use of SpaceOAR and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection, pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localized or more severe reaction, such as anaphylaxis), embolism (venous or arterial embolism is possible and may present outside of the pelvis, potentially impacting vital organs or extremities), syncope and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989811-AB

All images are the property of Boston Scientific.

All trademarks are the property of their respective owners.

Advantage Fit™ Transvaginal Mid-Urethral Sling System

For FEMALE Mid-Urethral Slings: Caution: U.S. Federal law restricts this device to sale by or on the order of a physician trained in use of surgical mesh for repair of stress urinary incontinence.

Refer to package insert provided with this product for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products.

The following adverse events have been reported due to suburethral sling placement, any of which may be ongoing, but are not limited to: As with all implants, local irritation at the wound site and/or a foreign body response may occur, Foreign body reaction may be acute or chronic, Pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia) (acute or chronic), Dyspareunia, Tissue responses to the mesh implant could include: erosion into organs (urethra, bladder or other surrounding tissues); exposure/extrusion into the vagina, Mesh contact with urine via erosion/exposure/extrusion may result in stone formation, scarring/scar contracture, Necrosis, fistula formation (acute or chronic), inflammation (acute or chronic), Mesh contracture, Tissue contracture, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Pain with intercourse that may not resolve, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Sexual dysfunction, including the inability to have intercourse. Like all foreign bodies, the mesh may potentiate an existing infection. Allergic reaction has been reported. Known risks of surgical procedures for the treatment of incontinence include: pain, ongoing pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia), Severe, chronic pain, Apareunia, Leg weakness, Infection, De novo detrusor instability, Complete failure of the procedure/failure to resolve a patient’s stress urinary incontinence, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention), Bruising, bleeding (vaginal, hematoma formation), Abscess, Vaginal discharge, Dehiscence of vaginal incision, Edema and erythema at the wound site, Perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement. The following additional adverse events have been reported for the Solyx SIS System: Dysuria, Hematuria. The occurrence of these events may require surgical intervention and possible removal of the entire mesh. In some instances, these events may persist as a permanent condition after surgical intervention or other treatment. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.

Coaptite™ Urethral Bulking Injection

Indications for Use: The COAPTITE™ Injectable Implant is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincteric 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 EVENTS that may occur include: Urinary Tract Infection, Cystitis, Vulvovaginal Mycotic Infection, Urinary Retention, Urge Incontinence, Micturition Urgency, Pollakiuria, Hematuria, Nocturia, Urethritis non-infective, Hemorrhage Urinary Tract, dysuria, erosion, erythema, embolic phenomena, and vascular 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 The COAPTITE Injectable 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 The COAPTITE Injectable Implant. Women with peripheral vascular disease and prior pelvic surgery may be at increased risk for tissue erosion following injection of The COAPTITE Injectable Implant. 
• The COAPTITE Injectable Implant in patients with urethral or bladder neck strictures should not be used until the strictures have been corrected. 
• Use in patients with strictures may cause injury and/or urethral obstruction. 
• Avoid using in patients with non-viable tissue, e.g., history of significant pelvic irradiation, multiple pelvic surgeries, etc. Scar tissue and significantly compromised tissue will not coapt appropriately. 
• Avoid using in patients with very short urethras and who have had multiple surgeries for stress incontinence. These patients may experience urethral caruncle formation. 
• Over correction using the COAPTITE Injectable Implant may lead to obstruction. 
• Avoid injecting in blood vessels. The COAPTITE Injectable Implant injection into blood vessels may cause vascular occlusion 

PRECAUTIONS:

• The long-term safety and effectiveness of the COAPTITE Injectable Implant treatment has not been established. 
• Safety and effectiveness of the COAPTITE Injectable Implant in patients with the following conditions has not been established — Urinary incontinence due to detrusor instability, Bladder neuropathy, Nocturnal enuresis (bed wetting), Prolapsed bladder, Overflow incontinence, Functional incontinence. 
• Safety and effectiveness of the COAPTITE Injectable Implant in patients that are pregnant, or lactating has not been established. 
• The effect of the COAPTITE Injectable Implant on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effect of the COAPTITE Injectable Implant, is unknown. Therefore, the risks and benefits of the implant in women of childbearing potential should be carefully assessed. 
• Patients should be counseled that one or more repeat injection procedures may be required to achieve dryness or a satisfactory level of improvement in urinary incontinence. 

Disclaimers: Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in diagnostic and therapeutic cystoscopy. All trademarks are the property of their perspective owners.  WH-989707-AB MAY2023 

LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring

Product shown for informational purposes only — not meant as a promotion or offer for sale ù product pending CE Mark, not available for sale in the European Economic Area (EEA).

Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology

References:

1. Ibrahim A, Elhilali MM, Fahmy N, Carrier S, Andonian S. Double‐blinded prospective randomized clinical trial comparing regular and Moses modes of holmium laser lithotripsy. J Endourol. 2020;34:624–628.
2. Ibrahim A, Badaan S, Elhilali MM, Andonian S. Moses technology in a stone simulator. Can Urol Assoc J. 2018;12:127–130.
3. Large T, Nottingham C, Stoughton C, Williams Jr J, Krambeck A. Comparative study of holmium laser enucleation of the prostate with MOSES enabled pulsed laser modulation. Urology. 2020;136:196–201.
4. Optimization of BPH Treatment Using LEP (Laser Enucleation of Prostate). Patents Justia, Publication number 20190298449.
5. Kavoussi NL, Nimmagadda N, Robles J, et al. MOSES technology for holmium laser enucleation of the prostate: A prospective double‐blind randomized control trial. J Urol. 2021 Jul;206(1):104–8.

The use of MOSES™ Technology in Urology, enabled in the Lumenis Pulse 120H system, is contraindicated for patients who are unable to receive endoscopic treatments or are intolerant to prolonged anesthesia, as well as for resection or excision of large, vascularized organs.  Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1μm) wavelength.  Incorrect treatment settings can cause serious tissue damage.  The laser should be used only on tissues that are fully observable.  See the system user manual for a complete list of contraindications and risks.

The MOSES 2.0 Technology is inclusive of all MOSES 1.0 settings and features.

Boston Scientific acquired the global surgical business of Lumenis Ltd. Some registered names of products manufactured and sold by Boston Scientific may contain the term “Lumenis.” Lumenis is a registered trademark of Lumenis Be.

Rezūm™ Water Vapor Therapy

References:

1. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezūm water vapor thermal therapy for treatment of moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021 Sep;206(3):715–24. 
2. Mynderse LA, Hanson D, Robb RA, et al. Rezūm System water vapor treatment for lower urinary tract symptoms/benign prostatic hyperplasia: validation of convective thermal energy transfer and characterization with magnetic resonance imaging and 3-dimensional renderings. Urology. 2015 Jul;86(1):122–7. 
3. Chughtai B, Cutone B, Alshak M, et al. The impact of COVID-19 on the management of BPH: how can we manage the backlog of patients? J Quality Health Care Economics. 2020;3(5):000183.

The Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume 30cm3 ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.