CapSure™는 강력하고 안정적인 고정을 통해 외과의가 원하는 자신감을 제공합니다.
CapSure™는 강력하고 안정적인 고정을 통해 외과의가 원하는 자신감을 제공합니다.
영구 고정 장치는 장기간의 강력한 회복을 용이하게 하지만 다음과 같은 몇 가지 과제와 관련이 있을 수 있습니다.
커버가 있습니다
강합니다
신뢰할 수 있습니다
*전임상 데이터. 결과는 인간에 대한 성능과 상관관계가 없을 수 있습니다
재정의된 체결구 설계
316L 스테인리스 스틸
부드러운 PEEK 캡
PEEK는 치과용 임플란트, 심장 판막과 스텐트, 관절 보철물을 비롯한 여러 의료용 이식에 사용됩니다
90일 전임상 접착 연구 결과 P 제품 고정 시스템보다 CapSure™ 고정 시스템이 더 강력한 결과를 보였습니다.
Evaluation of a Novel Permanent Capped Helical Coil Fastener in a Porcine Model of Laparoscopic Ventral Hernia Repair
Arnab Majumder, Mojtaba Fayezizadeh, William W. Hope,
Yuri W. Novitsky • Surgical Endoscopy(내시경 복강경 외과학회지) 2016년 4월
전임상 데이터. 결과는 인간에 대한 성능과 상관관계가 없을 수 있습니다.
CapSure™ 체결구는 P 제품과 같이 쿠퍼 인대 및 하부 구조를 쉽게 관통합니다
P 제품에 대하여 t0에서는 강도 동일, 시간이 지나며 강도 증가
돼지 모델에서는 CapSure™ 고정 Ventralight™ ST 메쉬의 경우 t0에서 파열 강도가 더 크며(4.3%), 시술 후 6주차에 “P 제품”이 같은 시점(p = .0088)에 Ventralight™ ST 메쉬를 고정한 것보다 피크 파열 강도가 상당히 크다는 것(18.4%)이 파열 강도 시험에서 입증되었습니다.
* 돼지 복벽 조직:
동물 데이터는 사람의 성능과 상관 관계가 없을 수 있습니다
* 돼지 6주 이식 연구:
동물 데이터는 사람의 성능과 상관 관계가 없을 수 있습니다
전달 시스템 성능에 대한 신뢰 개선
CapSure™ 체결구
CapSure™ 체결구는 메쉬 표면 적용범위가 2배이므로 메쉬가 제자리에 고정되어 있고 더 잘 보이도록 고정되어 있습니다. 3DMax™ 경량을 사용하여 벤치 테스트를 한 결과 P 제품에 비해 CapSure™이 대형 기공 메쉬를 유지할 가능성이 15배 더 높다는 것이 입증됨1
1. Bench top data. Results many not correlate to performance in humans.
2 Preclinical data. Results may not correlate to performance in humans
Indications
The CapSure™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Contraindications
Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera. Use of the CapSure™ Permanent Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is another 1 mm (total 4.2 mm).
Precautions
Adequate counter pressure should be applied on the target area. Avoid placing hand or finger directly over the area where fastener is being deployed to prevent injury. Use caution when applying the CapSure™ fastener over or in proximity to underlying bone, vessels, nerves, or viscera. The intended fixation site should be assessed to ensure that while the tissue is compressed the total distance from the surface of the tissue to any underlying structures is greater than the length of the CapSure™ fastener.
Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the CapSure™ Permanent Fixation System may include, but are not limited to the following: hemorrhage, pain, edema and erythema at wound site; septicemia/infection; hernia recurrence/wound dehiscence, erosion and allergic response in patients with known sensitivities to PEEK and metals contained in 316L stainless steel, including chromium, nickel, copper, and iron.
1. Bench top data. Results many not correlate to performance in humans.
2 Preclinical data. Results may not correlate to performance in humans
Indications
The CapSure™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Contraindications
Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera. Use of the CapSure™ Permanent Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is another 1 mm (total 4.2 mm).
Precautions
Adequate counter pressure should be applied on the target area. Avoid placing hand or finger directly over the area where fastener is being deployed to prevent injury. Use caution when applying the CapSure™ fastener over or in proximity to underlying bone, vessels, nerves, or viscera. The intended fixation site should be assessed to ensure that while the tissue is compressed the total distance from the surface of the tissue to any underlying structures is greater than the length of the CapSure™ fastener.
Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the CapSure™ Permanent Fixation System may include, but are not limited to the following: hemorrhage, pain, edema and erythema at wound site; septicemia/infection; hernia recurrence/wound dehiscence, erosion and allergic response in patients with known sensitivities to PEEK and metals contained in 316L stainless steel, including chromium, nickel, copper, and iron.
1. Bench top data. Results many not correlate to performance in humans.
2 Preclinical data. Results may not correlate to performance in humans
Indications
The CapSure™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Contraindications
Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera. Use of the CapSure™ Permanent Fixation System in the close vicinity of such underlying structures is contraindicated. For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is another 1 mm (total 4.2 mm).
Precautions
Adequate counter pressure should be applied on the target area. Avoid placing hand or finger directly over the area where fastener is being deployed to prevent injury. Use caution when applying the CapSure™ fastener over or in proximity to underlying bone, vessels, nerves, or viscera. The intended fixation site should be assessed to ensure that while the tissue is compressed the total distance from the surface of the tissue to any underlying structures is greater than the length of the CapSure™ fastener.
Adverse Reactions
Adverse reactions and potential complications associated with fixation devices such as the CapSure™ Permanent Fixation System may include, but are not limited to the following: hemorrhage, pain, edema and erythema at wound site; septicemia/infection; hernia recurrence/wound dehiscence, erosion and allergic response in patients with known sensitivities to PEEK and metals contained in 316L stainless steel, including chromium, nickel, copper, and iron.