FDA 设备许可:乳癌基因测试、椎间盘置换装置、数码膀胱镜


  January 22, 2008 — 美国食品药物管理局(FDA)核准对高风险乳癌病患之长期存活与肿瘤复发风险评估基因测试方式的上市前申请;也核准椎间盘置换装置用于骨骼成熟病患于单一椎间盘切除术后重建C3-C7,治疗棘手之有症状的椎间盘疾病;以及核准数码膀胱镜诊断输尿管和膀胱。
  
  乳癌基因测试 (TOP2A FISH pharmDx Assay)
  1月14日,FDA宣布核准一种基因检测方式(TOP2A FISH pharmDx assay, Dako Denmark A/S) 的上市前申请,这种检测用来判定相对高风险乳癌病患的肿瘤复发风险与长期存活。
  
  乳癌是美国妇女最常见的癌症之一,也是女性致死癌症的第二高,美国癌症学会估计,目前在美国有250万乳癌存活者。
  
  此一检测方式是首度获得核准用于评估临床乳癌组织样本的装置,观察拓朴异构酶(topoisomerase) 2 alpha (TOP2A)的状态改变,doxorubicin或epirubicin等药物将此DNA复制活化基因作为分子目标。
  
  椎间盘置换装置 (ProDisc-C)
  12月17日,FDA 核准一种椎间盘置换装置(ProDisc-C, Synthes Spine, Inc) ,用于骨骼成熟病患之单一椎间盘切除术后重建C3-C7椎间盘,治疗棘手之有症状椎间盘疾病(symptomatic cervical disc disease,SCDD)。
  
  SCDD是因为椎间盘疝气、退化性椎间盘疾病或者椎关节病变(骨刺)等引起的颈部和/或手臂疼痛,椎间盘置换可以解决会限制病患颈部动作的融合状况。
  
  这个新的装置,用手术置换两个邻近的脊椎,包含有两个金属内盘,固定到邻近脊椎的顶部和底部,塑料制镶嵌物固定在两个内盘之间。
  
  数码膀胱镜(CST-5000 Flexible Video Cystoscope) 诊断评估输尿管和膀胱
  12月18日,FDA核准数码膀胱镜(CST-5000 flexible video cystoscope, Vision-Science公司)用于诊断评估输尿管和膀胱。
  
  膀胱镜使用有光源的内视镜检查泌尿道,用于反覆泌尿道感染、血尿、尿失禁或频尿、排尿时疼痛或者有困难等的检查;对于发现肿瘤、膀胱结石、囊肿或者息肉、输尿管狭窄或者前列腺肥大等各种异常相当有用。
  
  CST-5000是一种重量轻、影像基础的可弯式内视镜,有内建光源,不需要额外的摄影镜头和光源线以及光学接头;此装置与Vision-Science公司的EndoSheath一起使用,EndoSheath 是一种可以提供操作通道的灭菌可抛弃式包覆鞘。

FDA Device Clearances: Genetic

By Jill Taylor
Medscape Medical News

January 22, 2008 — The US Food and Drug Administration (FDA) has approved a Premarket Application for a genetic test for the assessment of risk regarding tumor recurrence and long-term survival in patients with relatively high-risk breast cancer and has granted 510(k) clearance both for a cervical disc replacement device for reconstruction of the disc from C3 to C7 following single-level discectomy for intractable symptomatic cervical disc disease in skeletally mature patients and for a digital cystoscope for diagnostic evaluation of the urethra and bladder.

Genetic Test (TOP2A FISH pharmDx Assay) for Breast Cancer

On January 14, the FDA announced the approval of a Premarket Application for a genetic test (TOP2A FISH pharmDx assay, Dako Denmark A/S) to determine the risk for tumor recurrence and long-term survival in patients with relatively high-risk breast cancer.

Breast cancer is one of the most common forms of cancer in American women and is second only to lung cancer in causing cancer death in women. The American Cancer Society estimates that there are currently 2.5 million breast cancer survivors in the United States alone.

The device is the first test approved to assess clinical breast cancer tissue specimens for changes in the status of topoisomerase 2 alpha (TOP2A), a gene with an active role in DNA replication that is a molecular target of commonly used chemotherapeutic agents, such as doxorubicin or epirubicin.

Device (ProDisc-C) for Cervical Disc Replacement

On December 17, the FDA granted 510(k) clearance for a cervical disc replacement device (ProDisc-C, Synthes Spine, Inc) for reconstruction of the discs from C3 to C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD) in skeletally mature patients.

SCDD is a painful condition of the neck and/or arm resulting from disc herniation, degenerative disc disease, or spondylosis (bone spurs). Cervical disc replacement is an alternative to fusion, which can limit the patient's neck motion.

The new device is designed for surgical placement between 2 adjacent vertebral bodies in place of a diseased cervical disc and consists of 2 metal endplates, anchored to the top and bottom surfaces of the adjacent vertebral bodies, and a plastic inlay that fits between the 2 endplates.

Digital Cystoscope (CST-5000 Flexible Video Cystoscope) for Diagnostic Evaluation of the Urethra and Bladder

On December 18, the FDA granted 510(k) clearance for digital cystoscope (CST-5000 flexible video cystoscope, Vision-Science, Inc) for diagnostic evaluation of the urethra and bladder.

Cystoscopy, the use of a lighted endoscope for examination of the urinary tract, is performed in patients who have symptoms such as repeated urinary tract infections, blood in the urine, incontinence or frequent urination, pain, or difficulty in urination. The procedure is useful in uncovering a variety of abnormalities including tumors, bladder stones, cysts or polyps, narrowing of the urethra, or prostate gland enlargement.

The CST-5000 is a lightweight, video-based flexible endoscope that is used in conjunction with an integrated light source, which eliminates the need for a separate camera head, light guide cable, and optical coupler. The device is used in combination with Vision-Sciences' EndoSheath, a sterile, disposable cover that provides an operative channel.

    
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