Patients should always discuss the potential risks and benefits with a physician.
Indications (when to use): The ACT system is indicated for use in the correction of stress urinary incontinence in females.
Contraindications (when not to use): Contraindications include active systemic or urinary tract infections, pregnancy, unmanageable detrusor instability, reduced bladder compliance, pretreatment urge incontinence symptoms refractory to medication, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer or bladder stones, bleeding disorders.
Warnings/Precautions/Adverse Events: The ACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ACT device must be performed by a physician. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If ACT balloon failure, or bladder, urethra or vaginal wall perforation occur, the ACT device should not be implanted on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. If the patient becomes pregnant after ACT implantation, the primary physician must closely monitor the patient for any adverse effects associated with the device during pregnancy. ACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. Refrain from heavy lifting and exercise for 3 to 4 weeks postoperatively and refrain from intercourse for one month. Contact the surgeon immediately if bleeding or other problems occur. Potential adverse events include, but are not limited to tissue perforation (tear), device migration (movement), tissue erosion or infection at the implant site, device failure, non-response to treatment, post-operative urgency, frequency or retention.
Rx Only.
Patients should always discuss the potential risks and benefits with a physician.
Indications (when to use): The ProACT system is indicated for use in the correction of stress urinary incontinence in males arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for BPH.
Contraindications (when not to use): Contraindications include active systemic or urinary tract infections, unmanageable detrusor instability, reduced bladder compliance, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ProACT system implantation, bladder cancer, unsuccessfully treated bladder stones, hemophilia or bleeding disorders.
Warnings/Precautions/Adverse Events: The ProACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ProACT device must be performed by a physician. The ProACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If bladder perforation occurs, do not implant the ProACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. ProACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. Potential adverse events include, but are not limited to tissue perforation (tear), device migration (movement), post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure, and non-response to treatment.
Rx Only.
Product Technical manual must be reviewed prior to use for detailed disclosure.
Indications: The ACT system is indicated for use in the correction of stress urinary incontinence in females.
Contraindications: Contraindications include active systemic or urinary tract infections, pregnancy, unmanageable detrusor instability, reduced bladder compliance, pretreatment urge incontinence symptoms refractory to medication, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ACT system implantation, bladder cancer or bladder stones, bleeding disorders.
Warnings/Precautions/Adverse Events: The ACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ACT device must be performed by a physician. If X-ray is used, adequate attention must be given to the potential radiation exposure. Perforation of the bladder, urethra or vagina during dilation of the tissue from the labia to the bladder neck should be avoided. Do not use excessive force to advance or withdraw the device if resistance is encountered. Do not attempt to place or introduce the device without the supplied push wire. Do not place the device in a location where the patient may have problems with urinary retention or erosion. Do not place the device immediately adjacent to the urethral mucosa. This could result in balloon erosion or migration. Do not place the device in a location where there are surgical staples, steel suture or other artifacts from previous interventions. Device wear and/or puncture may result. Do not inflate the balloon with more than 8.0 ml of isotonic contrast solution. Use the correct mixture of sterile water and contrast media to provide an isotonic contrast solution for inflation of the ACT balloons. Do not use the implantation instruments without prior cleaning and steam sterilization. The ACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If ACT balloon failure, or bladder, urethra or vaginal wall perforation occur, do not implant and ACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. If the patient becomes pregnant after ACT implantation, the primary physician must closely monitor the patient for any adverse effects associated with the device during pregnancy. Failure of the device may result if the ACT device is handled with any sharp instruments or laid against an abrasive material. ACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. It is advisable to use the same type of contrast media as used during the original filling of the balloons when performing a post surgical adjustment. The patient should refrain from heavy lifting and exercise for 3 to 4 weeks postoperatively and refrain from intercourse for one month. Advise the patient to contact the surgeon immediately if bleeding or other problems occur. Potential adverse events include, but are not limited to tissue perforation (tear), device migration, tissue erosion/infection at the implant site, device failure, non-response to treatment, post-operative urgency, frequency or retention.
Rx Only.
Product Technical manual must be reviewed prior to use for detailed disclosure.
Indications: The ProACT system is indicated for use in the correction of stress urinary incontinence in males arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for BPH.
Contraindications: Contraindications include active systemic or urinary tract infections, unmanageable detrusor instability, reduced bladder compliance, residual volume greater than 100 ml after voiding, pelvic-region radiotherapy within 6 months of ProACT system implantation, bladder cancer, unsuccessfully treated bladder stones, hemophilia or bleeding disorders.
Warnings/Precautions/Adverse Events: The ProACT device is intended for single use only. Do not re-sterilize. Resterilization could result in mechanical failure of the device and place the patient at undue risk. Placement of the ProACT device must be performed by a physician. If X-ray is used, adequate attention must be given to the potential radiation exposure. Perforation of the bladder, urethra or rectum during dilation of the tissue from the perineal area to the bladder neck should be avoided. Do not use excessive force to advance or withdraw the device if resistance is encountered. Do not attempt to place or introduce the device without the supplied push wire. Do not place the device in a location where the patient may have problems with urinary retention or erosion. Do not inflate the balloon with more than 8.0 cc. Do not place the device immediately adjacent to the urethral mucosa. This could result in balloon erosion or migration. Use the correct mixture of sterile water and contrast media to provide an isotonic contrast solution for inflation of the ProACT balloons. Do not use the implantation instruments without prior cleaning and steam sterilization. Do not place the device in a location where there are surgical staples, steel suture or other artifacts from previous interventions. Device wear and/or puncture may result. The ProACT system should only be used by a physician who has completed appropriate training. Patients should be pre-medicated with an antibiotic to reduce the possibility of postoperative infection. If bladder perforation occurs, do not implant the ProACT device on the affected side for at least sixty days. An effective procedure calls for two devices to be placed. Failure of the device may result if the ProACT device is handled with any sharp instruments or laid against an abrasive material. Do not grasp the port or strain relief with clamps. ProACT balloons should be filled with saline instead of isotonic contrast solution if the patient is allergic to contrast media. It is advisable to use the same type of contrast media as used during the original filling of the balloons when performing a post surgical adjustment. Potential adverse events include, but are not limited to tissue perforation (tear), device migration, post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure, and non-response to treatment.
Rx Only.
Patienten sollten Nutzen und mögliche Risiken stets mit einem Arzt besprechen.
Anwendungsgebiete: Das ACT-System ist zur Korrektur der weiblichen Belastungsinkontinenz angezeigt.
Kontraindikationen: Das ACT-System darf nicht angewendet werden bei aktiven systemischen Infektionen oder Harnwegsinfektionen, Schwangerschaft, nicht behandelbarer Detrusorinstabilität, verminderter Compliance (Dehnbarkeit) der Blase, bereits bestehenden, therapierefraktären Symptomen einer Dranginkontinenz, einem Restharnvolumen von mehr als 100 ml nach Blasenentleerung, Strahlentherapie im Beckenbereich innerhalb von 6 Monaten nach Implantation des ACT-Systems, Blasenkrebs oder Blasensteinen, Blutgerinnungsstörungen.
Warnhinweise/Vorsichtsmaßnahmen/Unerwünschte Ereignisse: Das ACT-System ist nur zur einmaligen Anwendung bestimmt. Nicht resterilisieren. Eine Resterilisation kann zu mechanischem Versagen des Systems führen und die Patienten einem übermäßigen Risiko aussetzen. Die Implantation des ACT-Systems muss von einem Arzt vorgenommen werden. Das ACT-System sollte nur von einem Arzt implantiert werden, der ein entsprechendes Training absolviert hat. Um die Gefahr einer postoperativen Infektion zu reduzieren, sollten die Patienten mit einem Antibiotikum vorbehandelt werden. Falls es zu einem Versagen der ACT-Ballons oder zu einer Perforation der Blase, der Harnröhre oder der Vaginalwand kommt, darf das ACT-System an der betroffenen Seite für mindestens sechzig Tage nicht implantiert werden. Voraussetzung für einen erfolgreichen Verlauf des Eingriffs ist die Implantation zweier Ballons. Sollte die Patientin nach Implantation des ACT-Systems schwanger werden, muss der behandelnde Arzt die Patientin während der Schwangerschaft engmaschig auf unerwünschte Wirkungen des Systems überwachen. Falls eine Allergie gegen Kontrastmittel besteht, sollten die ACT-Ballons statt mit isotonischer Kontrastmittellösung mit Kochsalzlösung befüllt werden. Nach der Operation sollten Sie für drei bis vier Monate auf das Heben schwerer Gegenstände, Sport sowie für einen Monat auf Geschlechtsverkehr verzichten. Sollten Blutungen oder andere Probleme auftreten, wenden Sie sich sofort an den Operateur. Zu den möglichen unerwünschten Ereignissen gehören unter anderem Perforation (Einreißen) von Gewebe, Migration (Wandern) des Systems, Gewebeerosion oder -infektion an der Implantationsstelle, Versagen des Systems, Unwirksamkeit der Behandlung, gesteigerter Harndrang, erhöhte Miktionsfrequenz oder Harnverhaltung nach der Operation.
Patienten sollten Nutzen und die möglichen Risiken stets mit einem Arzt besprechen.
Anwendungsgebiete: Das ProACT-System ist angezeigt zur Korrektur der Belastungsinkontinenz bei Männern, die durch einen intrinsischen Sphinkterdefekt (ISD) nach einer Prostataoperation zur Krebs- oder BPH-Therapie hervorgerufen wurde.
Kontraindikationen: Das ProACT-System darf nicht angewendet werden bei aktiven systemischen Infektionen oder Harnwegsinfektionen, nicht behandelbarer Detrusorinstabilität, verminderter Compliance (Dehnbarkeit) der Blase, einem Restharnvolumen von mehr als 100 ml nach Blasenentleerung, Strahlentherapie im Beckenbereich innerhalb von 6 Monaten nach Implantation des ProACT-Systems, Blasenkrebs, nicht erfolgreich behandelten Blasensteinen, Hämophilie oder Blutgerinnungsstörungen.
Warnhinweise/Vorsichtsmaßnahmen/Unerwünschte Ereignisse: Das ProACT-System ist nur zur einmaligen Anwendung bestimmt. Nicht resterilisieren. Eine Resterilisation kann zu mechanischem Versagen des Systems führen und die Patienten einem übermäßigen Risiko aussetzen. Die Implantation des ProACT-Systems muss von einem Arzt vorgenommen werden. Das ProACT-System sollte nur von einem Arzt implantiert werden, der ein entsprechendes Training absolviert hat. Um die Gefahr einer postoperativen Infektion zu reduzieren, sollten die Patienten mit einem Antibiotikum vorbehandelt werden. Bei Auftreten einer Blasenperforation darf das ProACT-System auf der betroffenen Seite für mindestens sechzig Tage nicht implantiert werden. Voraussetzung für einen erfolgreichen Verlauf des Eingriffs ist die Implantation zweier Ballons. Falls eine Allergie gegen Kontrastmittel besteht, sollten die ProACT-Ballons statt mit isotonischer Kontrastmittellösung mit Kochsalzlösung befüllt werden. Zu den möglichen unerwünschten Ereignissen gehören unter anderem Perforation (Einreißen) von Gewebe, Migration (Wandern) des Systems, gesteigerter Harndrang, erhöhte Miktionsfrequenz oder Harnverhaltung nach der Operation, Gewebeerosion/-infektion an der Implantationsstelle, Versagen des Systems und Unwirksamkeit der Behandlung.
Il paziente deve discutere con il medico rischi e benefici del dispositivo.
Indicazioni (quando utilizzare la terapia): Il sistema ACT è indicato nella correzione dell’incontinenza urinaria da sforzo in pazienti donne.
Controindicazioni (quando non utilizzare la terapia): Le controindicazioni comprendono infezioni attive sistemiche o delle vie urinarie, gravidanza, instabilità intrattabile del detrusore, ridotta elasticità della vescica, sintomi pretrattamento di incontinenza da urgenza refrattari a farmaci, volume residuo superiore a 100 ml dopo la minzione, radioterapia nell’area pelvica entro 6 mesi dall’impianto del sistema ACT, carcinoma vescicale o calcoli vescicali, disordini della coagulazione.
Avvertenze/Precauzioni/Eventi avversi:: Il dispositivo ACT è esclusivamente monouso. Non risterilizzare, La risterilizzazione può comportare il guasto meccanico del dispositivo e sottoporre il paziente a un rischio eccessivo. L’impianto del dispositivo ACT deve essere eseguito da un medico. Il sistema ACT deve essere utilizzato solamente da medici con idonea preparazione. Per ridurre la possibilità di un’infezione postoperatoria, i pazienti devono essere preventivamente medicati con un antibiotico. Se si verifica un guasto ai palloncini o la perforazione della parete vescicale, uretrale o vaginale, è necessario sospendere l’impianto del dispositivo nel sito interessato per almeno sessanta giorni. Un intervento efficace esige il posizionamento di due dispositivi. Se la paziente entra in gravidanza dopo l’impianto del sistema ACT, il medico curante deve tenerla in stretta osservazione per la tempestiva rilevazione di eventuali effetti avversi associati al dispositivo durante la gravidanza. Se la paziente è allergica ai mezzi di contrasto, occorre riempire i palloncini del sistema ACT con soluzione salina invece che con soluzione isotonica di contrasto. Astenersi dal sollevamento di pesi e dall’esercizio fisico per 3-4 mesi dopo l’intervento e da rapporti sessuali per un mese. In caso di emorragia o altri disturbi, contattare immediatamente il chirurgo. I possibili eventi avversi comprendono, fra l’altro, perforazione di tessuti (lacerazione), migrazione del dispositivo (spostamento), erosione di tessuti o infezione al sito di impianto, guasto del dispositivo, assenza di risposta al trattamento, urgenza, frequenza o ritenzione postoperatoria.
Solo su prescrizione medica.
Il paziente deve discutere con il medico rischi e benefici del dispositivo.
Indicazioni (quando utilizzare la terapia): Il sistema ProACT è indicato per la correzione dell’incontinenza urinaria da sforzo dovuta a deficienza sfinterica intrinseca in seguito a intervento alla prostata per neoplasia prostatica o iperplasia prostatica benigna (IPB).
Controindicazioni (quando non utilizzare la terapia): Le controindicazioni comprendono infezioni attive sistemiche o delle vie urinarie, instabilità intrattabile del detrusore, ridotta elasticità della vescica, volume residuo superiore a 100 ml dopo la minzione, radioterapia nell’area pelvica entro 6 mesi dall’impianto del sistema ProACT, carcinoma vescicale, calcoli vescicali trattati senza successo o disordini della coagulazione.
Avvertenze/Precauzioni/Eventi avversi:: Il dispositivo ProACT è esclusivamente monouso. Non risterilizzare, La risterilizzazione può comportare il guasto meccanico del dispositivo e sottoporre il paziente a un rischio eccessivo. L’impianto del dispositivo ProACT deve essere eseguito da un medico. Il sistema ProACT deve essere utilizzato solamente da medici con idonea preparazione. Per ridurre la possibilità di un’infezione postoperatoria, i pazienti devono essere preventivamente medicati con un antibiotico. Se si verifica una perforazione delle pareti vescicali, è necessario sospendere l’impianto del dispositivo nel sito interessato per almeno sessanta giorni. Un intervento efficace esige il posizionamento di due dispositivi. Se il paziente è allergico ai mezzi di contrasto, occorre riempire i palloncini del sistema ProACT con soluzione salina invece che con soluzione isotonica di contrasto. I possibili eventi avversi comprendono, fra l’altro, perforazione di tessuti (lacerazione), migrazione del dispositivo (spostamento), urgenza, frequenza o ritenzione postoperatoria, erosione di tessuti o infezione al sito di impianto, guasto del dispositivo e assenza di risposta al trattamento.
Solo su prescrizione medica.
—This page last modified Tuesday May 13, 2008