FDA核准:Discovery、Blastocyst Vitrification Kit、 Cool-tip


  May 9, 2006 — 美國食品藥物管理局(FDA)核准雙能量X光吸收儀一個新的適應症,准其用於藉由看到腹腔大主動脈的鈣化現象,以判斷心血管疾病;囊胚玻璃化冷凍產品可以比傳統慢速冷凍方式提高受孕率;射頻燒灼治療系統用於治療無法切除性肝臟損害和骨內類骨質骨瘤。
  
  DXA Test (Discovery) 藉由看到腹腔大主動脈的鈣化現象以判斷心血管疾病
  FDA在五月核准雙能量X光吸收儀(DXA) (Discovery,Hologic製造)一個新的適應症,准其用於藉由看到腹腔大主動脈的鈣化現象(AAC),以判斷冠心病、中風和各種心血管疾病。
  
  此裝置本來設計用以快速且準確測量骨質密度和脊椎骨折(骨質疏鬆症的兩項主要診斷依據),進行一標準的、低劑量、10秒鐘脊椎測量(IVA)。
  
  IVA掃描也可用於AAC,AAC是傳統臨床心血管風險因子(如膽固醇、血壓、糖尿病、年紀等等)之外造成心血管疾病的另一個原因;根據該公司的新聞稿,AAC對停經後婦女而言更是重要風險因素,而停經後婦女也是特別需要骨質疏鬆評估的一群。
  
  IVF冷凍產品 (Blastocyst Vitrification Kit)可以提高受孕率
  4月24日,FDA核准一囊胚玻璃化冷凍產品(Blastocyst Vitrification Kit [Vit Kit]、Irvine Scientific Sales Company製造);整套產品包括可以達到超快速冷凍之細胞冷凍保存媒介、以及包含一個經體外受孕的第5天人類胚胎,以及解凍/恢復媒介以使樣本適當地復原。
  
  這個新產品在歷經將近5年的研發和核准程序之後,5月5日開始在美國上市。
  
  根據該公司的新聞稿,這一項新的玻璃化冷凍技術可以比傳統慢速冷凍方式提高受孕率;不像慢速冷凍技術,玻璃化冷凍方法還包括脫水、可以避免在經液態氮冷凍的過程中產生傷害細胞的冰晶。
  
  此方法在歐洲、日本和南美洲廣泛被用來幫助希望保存其生育力的癌症病患在化療前冷凍卵子、以及幫助那些追求學業深造或者發展事業的年輕女性保存卵子。
  
  射頻燒灼治療系統(Cool-tip)用於無法切除的肝腫瘤
  2月3日,FDA核准一種射頻(RF)燒灼治療系統(Cool-tip,Tyco Healthcare Group LP旗下的Valleylab製造) 用於經皮穿刺、腹腔鏡、手術中血液凝固、和組織燒灼;運用在無法切除的肝損傷的部分或者全部燒灼、以及骨內類骨質骨瘤。
  
  根據該公司的新聞稿,此裝置對不適合接受捐肝手術的肝癌病患、或者其他治療方式失敗的病患提供一種微創治療選擇。
  
  整套系統包括以微處理器做基礎的內建17-gauge冷式針狀電極(單一或一束) RF產生器、產生200瓦的RF能量直射腫瘤;使用電腦斷層攝影或超音波等影像技術導引針頭到達燒灼部位;燒灼時電極內有水流循環以冷卻相鄰的組織、因而達到在最短時間內以最大RF能量進行更多的燒灼。

FDA Approvals: Discovery, Blas

By Yael Waknine
Medscape Medical News

May 9, 2006 — The US Food and Drug Administration (FDA) has approved a new indication for a dual-energy X-ray absorptiometry system, allowing its use to visualize abdominal aortic calcification as a predictor of cardiovascular disease; a vitrification product for blastocysts that is associated with higher pregnancy success rates compared with conventional slow-freezing techniques; and a radiofrequency ablation system for the treatment of nonresectable liver lesions and osteoid osteoma tumors within bone.


DXA Test (Discovery) for Visualization of Abdominal Aortic Calcification as Predictor of CV Disease

The FDA approved in May a new indication for a dual-energy X-ray absorptiometry (DXA) system (Discovery, made by Hologic, Inc), allowing its use to visualize abdominal aortic calcification (AAC) as a predictor of coronary heart disease, stroke, and other forms of cardiovascular disease.

The device is designed to quickly and precisely measure bone mineral density and vertebral fractures (the 2 primary diagnostic indicators of osteoporosis) using a standard, low-dose, 10-second vertebral assessment (IVA) test.

The IVA scans can also be used for AAC visualization, which contributes to cardiovascular disease risk independently of traditional clinical risk factors such as cholesterol, blood pressure, diabetes, and age. According to a company news release, AAC appears to be a particularly strong risk factor in postmenopausal women, a population that is also in greatest need of osteoporosis assessment.


IVF Freezing Product (Blastocyst Vitrification Kit) Linked to Higher Pregnancy Success Rates

On April 24, the FDA approved a vitrification product for blastocysts (Blastocyst Vitrification Kit [Vit Kit], made by Irvine Scientific Sales Company, Inc). The kit contains cryopreservation media for the ultra-rapid freezing and containment of day 5 human embryos from an in-vitro fertilization procedure, and thawing/recovery media to optimize specimen recovery.

The novel device was launched in the US market on May 5, after a nearly 5-year development and regulatory review process.

According to a company news release, the new cryopreservation method is associated with significantly higher pregnancy success rates compared with conventional techniques. Unlike slow-freezing techniques, vitrification involves dehydrating the cells and then very rapidly cooling them in liquid nitrogen to avoid the formation of damaging ice crystals.

The procedure has been widely used in Europe, Japan, and South America as a means of preserving fertility for cancer patients who wish to freeze their eggs prior to chemotherapy, and for young women wishing to postpone pregnancy while they pursue higher education and/or advance their careers.


Radiofrequency Ablation System (Cool-tip) for Nonresectable Hepatic Tumors

On February 3, the FDA approved a radiofrequency (RF) ablation system (Cool-tip, made by Valleylab, a division of Tyco Healthcare Group LP) for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of nonresectable liver lesions and osteoid osteoma tumors within bone.

According to a company news release, the device offers a minimally invasive alternative for patients with hepatic cancer who are not ideal surgical candidates or are otherwise unable to be successfully treated with other methods.

The system combines a microprocessor-based RF generator with a 17-gauge internally cooled needle electrode (single or cluster configuration) to deliver 200 watts of RF energy directly to the tumor. Imaging technology such as computed tomography or ultrasound is used to guide the needle to the ablation site. Water is circulated internally through the electrode during ablation to cool adjacent tissue, thereby maximizing delivery of RF energy and creating the largest ablation possible in a minimal amount of time.

Reviewed by Gary D. Vogin, MD

    
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