SorboFix™ 흡수성 고정 시스템의 독특한 고정 장치 설계로 환자 및 의사 날카로운 부분이 남지 않도록 설계되어 있습니다. 진정한 데이터에 따르면, 흡음 구조는 조직에 고정 장치를 둘러싸여 자리하도록 도와줍니다. 5mm 깊이의 조직 고정력과 헤드에서 끝까지 밀집된 나사 직경은 수술 과정의 조직 접촉을 보호합니다. SorboFix™ 흡수성 고정 시스템은 5mm 직경의 전립기를 사용하여 부드럽고 효율적인 장치 삽입이 가능합니다. 15개 또는 30개 고정장치가 시간 효율적인 옵션 확인을 위해 고정 장치 캐리어가 함께 추가되었습니다.
true
지원
Becton, Dickinson and Company
(82.2) 080-340-3800
bd_korea@bd.com
영업팀에 연락해 주셔서 감사합니다!
영업 담당자가 곧 연락을 드립니다.
Address
Becton Dickinson Korea Co., Ltd. 한국 서울특별시 강남구 테헤란로 142 아크플레이스 16층 06236
- 개요
- 관련 제품
- 자원 및 교육
스마트하지만, 날카롭지 않은 설계
true
강력한 고정력:
- 최대 복강내압(IAP)보다 회복 강도가 약 7배 더 강합니다. 1, 2
- 나사형 중공 구조는 고정 장치 내부를 통해 조직이 자라도록 도움을 줍니다. 2
전단 강도 유지력은 시간 경과에 따른 SorbaFix™ 고정 장치의 분해되는 것을 보여줍니다. SorbaFix™ 고정 장치는 초기 2개월 간 강도를 100% 유지하며, 초기 회복 기간 동안 안정적인 고정을 제공합니다.2
본 데이터는 전임상 결과이며, 사람에서의 성능과 일치하지 않을 수 있습니다.
일관된 설계:
- 헤드부터 팁까지 나사의 직경과 고정 장치 길이가 일정하게 유지되어 조직 접합을 극대화하도록 설계되었습니다.
- 파일럿 팁이 포함된 옵튜레이터는 고정 장치가 메쉬와 조직에 안착하도록 정확히 유도합니다.
신뢰할 만한 안정성:
- 둥근 팁과 매끄러운 헤드 덕에 외상 유발이 없고, 날카로운 부분이 노출되지 않아 안전합니다.
- 혁신적인 기기 설계를 통해 내구성 있는 삽입 시스템이 가능해졌습니다.
- PDLLA(폴리 D, L-젖산) 고정 장치는 이식 후 약 12개월 시점에 거의 완전히 흡수되어, 체내에 남는 이물질을 최소화합니다.
Twardowski ZJ et al “Intraabdominal Pressures during Natural Activities in Patients Treated with Continuous Ambulatory Peritoneal Dialysis” Nephron 44:129-135 1986. Cobb WS et al. "The Argument for Lightweight Polypropylene Mesh in Hernia Repair" Surgical Innovation. Vol 12 (1).63-69, 2005.
Data generated from an animal study using the SORBAFIX™ Absorbable Fixation System and from a cadaver study using the PERMAFIX™ Permanent Fixation System. Data on file. Results may not correlate to performance in humans.
Indications
The SorbaFix™ Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during laparoscopic surgical procedures, such as hernia repair.
Contraindications
This device is not intended for use except as indicated. Do not use this device where hemostasis cannot be verified visually after application. Contraindications associated with laparoscopic surgical procedures relative to mesh fixation apply, including but not limited to: Fixation of vascular or neural structures, Fixation of bone and cartilage, Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is resorbed. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera, or bone. Use of the SorbaFix™ Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).:
Warnings
The SorbaFix™ Absorbable Fixation System is intended for Single Use Only – DO NOT RESTERILIZE. Reuse, reprocessing, re-sterilization, or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, re-sterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user. This product is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use. Do not use beyond the expiration date on the package. Do not use if the center of the temperature indicator is black. As with any implant material the presence of bacterial contamination may enhance bacterial infectivity. Accepted surgical practices must be followed with respect to drainage and closure of infected or contaminated wounds. Users should be familiar with surgical procedures and techniques involving synthetic absorbable materials before employing SorbaFix™ Absorbable Fixation System fasteners for wound closure, as the risk of wound dehiscence may vary with the site of application and the material used. The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetics should be evaluated for compatibility prior to use. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel, and viscera when entering the surgical site, manipulating tissue, and fixating mesh. After use, the SorbaFix™ Absorbable Fixation System may be a potential biohazard. This device has a piloting tip, which should be considered a sharp even when the device is not actuated. Handle and dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries.
Precautions
Please read all instructions before using the SorbaFix™ Absorbable Fixation System. Only persons having adequate medical training and familiarity with surgical techniques should perform surgical procedures. Consult the medical literature relative to technique, complications, and hazards prior to any surgical procedure. The SorbaFix™ Absorbable Fixation System can be used with most 5 mm trocars. Ensure compatibility by inserting the device into the trocar prior to introduction into the patient. The SorbaFix™ Absorbable Fixation System should enter and exit the trocar easily without excessive force. The use of too much force could damage the instrument. Counter pressure should be applied on the target area. Avoid placing hand/finger directly over the area where the fastener is being deployed to prevent injury. Insertion of fasteners into some collagenous structures such as ligaments and tendons is possible but is NOT possible directly into bone or cartilage. This may damage the device. Avoid excessive trigger force as this may damage the device. If the device locks, remove the device from the patient and lightly tap the trigger forward toward the tip to release. If the device locks and cannot be separated from a fastener that has been deployed into tissue, you may rotate the device counterclockwise to free the device. The locked device should then be discarded, and a new device should be used. If the fastener does not deploy properly, remove the device from the patient and test the device in air to ensure proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into the patient. The safety and effectiveness of SorbaFix™ Absorbable Fixation System have not been evaluated or established in pregnant or breast feeding women. This device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports that medical devices manufactured from stainless-steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. For more information, please consult the ECHA website: Homepage - ECHA .
Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema, and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.
Please consult package insert for more detailed safety information and instructions for use.
true
1. Twardowski ZJ et al “Intraabdominal Pressures during Natural Activities in Patients Treated with Continuous Ambulatory Peritoneal Dialysis” Nephron 44:129-135 1986. Cobb WS et al. "The Argument for Lightweight Polypropylene Mesh in Hernia Repair" Surgical Innovation. Vol 12 (1).63-69, 2005.
2. Data generated from an animal study using the SORBAFIX™ Absorbable Fixation System and from a cadaver study using the PERMAFIX™ Permanent Fixation System. Data on file. Results may not correlate to performance in humans.
Indications
The SorbaFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during laparoscopic surgical procedures, such as hernia repair.
Contraindications
This device is not intended for use except as indicated. Do not use this device where hemostasis cannot be verified visually after application. Contraindications associated with laparoscopic surgical procedures relative to mesh fixation apply, including but not limited to: Fixation of vascular or neural structures, Fixation of bone and cartilage, Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is resorbed. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera, or bone. Use of the SorbaFix™ Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).:
Warnings
The SorbaFix™ Absorbable Fixation System is intended for Single Use Only – DO NOT RESTERILIZE. Reuse, reprocessing, re-sterilization, or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, re-sterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user. This product is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use. Do not use beyond the expiration date on the package. Do not use if the center of the temperature indicator is black. As with any implant material the presence of bacterial contamination may enhance bacterial infectivity. Accepted surgical practices must be followed with respect to drainage and closure of infected or contaminated wounds. Users should be familiar with surgical procedures and techniques involving synthetic absorbable materials before employing SorbaFix™ Absorbable Fixation System fasteners for wound closure, as the risk of wound dehiscence may vary with the site of application and the material used. The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetics should be evaluated for compatibility prior to use. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel, and viscera when entering the surgical site, manipulating tissue, and fixating mesh. After use, the SorbaFix™ Absorbable Fixation System may be a potential biohazard. This device has a piloting tip, which should be considered a sharp even when the device is not actuated. Handle and dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries.
Precautions
Please read all instructions before using the SorbaFix™ Absorbable Fixation System. Only persons having adequate medical training and familiarity with surgical techniques should perform surgical procedures. Consult the medical literature relative to technique, complications, and hazards prior to any surgical procedure. The SorbaFix™ Absorbable Fixation System can be used with most 5 mm trocars. Ensure compatibility by inserting the device into the trocar prior to introduction into the patient. The SorbaFix™ Absorbable Fixation System should enter and exit the trocar easily without excessive force. The use of too much force could damage the instrument. Counter pressure should be applied on the target area. Avoid placing hand/finger directly over the area where the fastener is being deployed to prevent injury. Insertion of fasteners into some collagenous structures such as ligaments and tendons is possible but is NOT possible directly into bone or cartilage. This may damage the device. Avoid excessive trigger force as this may damage the device. If the device locks, remove the device from the patient and lightly tap the trigger forward toward the tip to release. If the device locks and cannot be separated from a fastener that has been deployed into tissue, you may rotate the device counterclockwise to free the device. The locked device should then be discarded, and a new device should be used. If the fastener does not deploy properly, remove the device from the patient and test the device in air to ensure proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into the patient. The safety and effectiveness of SorbaFix™ Absorbable Fixation System have not been evaluated or established in pregnant or breast feeding women. This device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports that medical devices manufactured from stainless-steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. For more information, please consult the ECHA website: https://echa.europa.eu/home.
Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema, and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.
Please consult package insert for more detailed safety information and instructions for use.
true
true
1. Twardowski ZJ et al “Intraabdominal Pressures during Natural Activities in Patients Treated with Continuous Ambulatory Peritoneal Dialysis” Nephron 44:129-135 1986. Cobb WS et al. "The Argument for Lightweight Polypropylene Mesh in Hernia Repair" Surgical Innovation. Vol 12 (1).63-69, 2005.
2. Data generated from an animal study using the SORBAFIX™ Absorbable Fixation System and from a cadaver study using the PERMAFIX™ Permanent Fixation System. Data on file. Results may not correlate to performance in humans.
Indications
The SorbaFix™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during laparoscopic surgical procedures, such as hernia repair.
Contraindications
This device is not intended for use except as indicated. Do not use this device where hemostasis cannot be verified visually after application. Contraindications associated with laparoscopic surgical procedures relative to mesh fixation apply, including but not limited to: Fixation of vascular or neural structures, Fixation of bone and cartilage, Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is resorbed. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera, or bone. Use of the SorbaFix™ Absorbable Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).:
Warnings
The SorbaFix™ Absorbable Fixation System is intended for Single Use Only – DO NOT RESTERILIZE. Reuse, reprocessing, re-sterilization, or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, re-sterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user. This product is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use. Do not use beyond the expiration date on the package. Do not use if the center of the temperature indicator is black. As with any implant material the presence of bacterial contamination may enhance bacterial infectivity. Accepted surgical practices must be followed with respect to drainage and closure of infected or contaminated wounds. Users should be familiar with surgical procedures and techniques involving synthetic absorbable materials before employing SorbaFix™ Absorbable Fixation System fasteners for wound closure, as the risk of wound dehiscence may vary with the site of application and the material used. The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetics should be evaluated for compatibility prior to use. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel, and viscera when entering the surgical site, manipulating tissue, and fixating mesh. After use, the SorbaFix™ Absorbable Fixation System may be a potential biohazard. This device has a piloting tip, which should be considered a sharp even when the device is not actuated. Handle and dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries.
Precautions
Please read all instructions before using the SorbaFix™ Absorbable Fixation System. Only persons having adequate medical training and familiarity with surgical techniques should perform surgical procedures. Consult the medical literature relative to technique, complications, and hazards prior to any surgical procedure. The SorbaFix™ Absorbable Fixation System can be used with most 5 mm trocars. Ensure compatibility by inserting the device into the trocar prior to introduction into the patient. The SorbaFix™ Absorbable Fixation System should enter and exit the trocar easily without excessive force. The use of too much force could damage the instrument. Counter pressure should be applied on the target area. Avoid placing hand/finger directly over the area where the fastener is being deployed to prevent injury. Insertion of fasteners into some collagenous structures such as ligaments and tendons is possible but is NOT possible directly into bone or cartilage. This may damage the device. Avoid excessive trigger force as this may damage the device. If the device locks, remove the device from the patient and lightly tap the trigger forward toward the tip to release. If the device locks and cannot be separated from a fastener that has been deployed into tissue, you may rotate the device counterclockwise to free the device. The locked device should then be discarded, and a new device should be used. If the fastener does not deploy properly, remove the device from the patient and test the device in air to ensure proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into the patient. The safety and effectiveness of SorbaFix™ Absorbable Fixation System have not been evaluated or established in pregnant or breast feeding women. This device contains the following substance(s) defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports that medical devices manufactured from stainless-steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. For more information, please consult the ECHA website: https://echa.europa.eu/home.
Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the SorbaFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema, and erythema at wound site; allergic reaction to Poly (D, L)-lactide; septicemia/infection; hernia recurrence/wound dehiscence.
Please consult package insert for more detailed safety information and instructions for use.
true
true