FDA核准:Orbasone、Accufuser与Metricath Gemini


  Aug.19, 2005 - 美国食品药品管理局(FDA)核准一种激波治疗系统,以非侵入式方式治疗慢性足底筋膜炎,其为一局部麻灌注帮浦,降低手术后麻醉剂的使用及疼痛,为一具有内腔可测量特色的双气球导管测量能力,用来治疗外围动脉疾病。
  
  激波器材治疗脚后跟痛
  FDA在8月核准体外激波治疗系统(Orbasone,由Orthometrix公司制造),治疗慢性足底筋膜炎。
  
  此器材产生高能量激波,并藉著半椭圆反射器引导至治疗区,门诊患者可在整形外科医师或足科医师的监督下执行30到40分钟的疗程。
  
  此核准基于多中心、179位患者的控制临床试验,显示主动式医材从治疗3周后为基础线和安慰剂比较,可有效降低40%或以上的疼痛(69% vs 37%)。
  
  虽然某些患者报告得到立即的疼痛缓解,其它人则在经过6个月以上的时间,疼痛也渐渐缓解;与激波治疗有关的常见副作用为挫伤、肿块和疼痛。
  
  根据一家公司的新闻稿指出,此系统的相对低成本预计可增加3亿8千6百万罹患足底筋膜炎美国人的治疗效益。
  
  此激波医材早先已被加拿大、欧洲、和亚洲核准使用。
  
  局部麻灌注帮浦(Accufuser)降低手术后麻醉剂的使用
  3月23日,FDA核准局部麻醉灌注帮浦一项新的适应症(Accufuser 手术后疼痛控制帮浦,由 McKinley Medical,LLC所制造),允许其用来降低手术后接近神经附近伤口处麻醉剂的使用量及疼痛感。
  
  此携带式、非电子气球灌注器可连续或间歇式传递药物,它的特色为大药丸可自行使用额外的剂量来改善舒适程度。
  
  最近一项50位腹部拉皮术患者的临床试验显示,使用此帮浦比传统单独使用麻醉止痛剂而言,降低49%手术后麻醉止痛剂的使用量,患者使用此帮浦亦比未使用者快22%恢复行动能力,快21%开始恢复正常的活动力。
  
  此器材之前已被使用于手术后的疼痛管理和局部麻醉作用。
  
  多功能双气球外围导管(Metricath Gemini)用于血管修复术
  FDA于8月份核准多功能双气球导管 (Metricath Gemini,由Medical Ventures Corp的分公司Angiometrx制造,Possis Medical公司营销)。
  
  此导管结合高效能血管修复气球的治疗特色及动脉测量科技,允许医师精准的量测动脉尺寸和支架模块,并使用单一器材扩大血管。
  
  根据一家公司的新闻稿指出,此医材将在2005年第4季上市,售价和传统仅用于血管修复术的导管类似,美国核准其用在冠状动脉的临床试验即将展开,预计于2006年取得FDA的许可。

FDA Approvals: Orbasone, Accuf

By Yael Waknine
Medscape Medical News

Aug. 19, 2005 — The U.S. Food and Drug Administration (FDA) has approved a shockwave device for the noninvasive treatment of chronic plantar fasciitis; an local anesthetic infusion pump to decrease postsurgical narcotic use and pain; and a dual-balloon catheter with lumen measurement capability for use in the treatment of peripheral artery disease.

Shockwave Device (Orbasone) for Chronic Heel Pain

The FDA approved in August an extracorporeal shockwave therapy system (Orbasone, made by Orthometrix, Inc.) for the treatment of chronic plantar fasciitis.

The device produces high-energy shockwaves that are guided to the treatment area by a semi-ellipsoidal reflector in a 30- to 40-minute outpatient procedure performed under the supervision and care of an orthopaedic surgeon or podiatrist.

The approval was based on the results of a multisite, controlled clinical trial in 179 patients, showing that the active device was significantly more effective in achieving a 40% or greater reduction in pain from baseline at three months posttreatment compared with placebo (69% vs 37%).

Although immediate pain relief was reported by some patients, others experienced a gradual reduction in pain over a period of up to six weeks. The most commonly reported adverse events associated with use of shockwave therapy included bruising, swelling, and pain.

According to a company news release, the comparatively low cost of the system is expected to increase treatment availability for 38.6 million Americans with plantar fasciitis.

The shockwave device was previously approved for use in Canada, Europe, and Asia.

Local Anesthetic Infusion Pump (Accufuser) Decreases Postsurgical Narcotic Use

On March 23, the FDA approved a new indication for a local anesthetic infusion pump (Accufuser Post-Op Pain Control Pump, made by McKinley Medical, LLC), allowing its use in the reduction of narcotic use and pain when used at surgical wound sites or in close proximity to nerves.

The portable, nonelectronic balloon infuser can be used for continuous or intermittent delivery of medication. It features a bolus button for self-administration of additional doses to improve comfort.

Recently reported results of a clinical study in 50 abdominoplasty patients have shown that use of the pump decreased postoperative narcotic use by 49% compared with conventional narcotic administration alone. Patients using the pump also regained mobility 22% faster and resumed normal activities 21% faster than patients not using the pump.

The device was previously approved for use in postoperative pain management and delivery of regional anesthesia.

Multifunction Dual-Balloon Peripheral Catheter (Metricath Gemini) for Angioplasty

The FDA approved in August a multifunction dual-balloon catheter (Metricath Gemini, made by Angiometrx, a division of Medical Ventures Corp., and distributed by Possis Medical, Inc.) for use in the treatment of peripheral artery disease.

The catheter combines arterial measurement technology with the treatment capability of a high-performance angioplasty balloon, allowing physicians to precisely measure arterial size and stent deployment, and dilate a vessel using a single device.

According to a company news release, the device will be available in the fourth quarter of 2005 and priced similarly to typical angioplasty treatment-only catheters. Clinical trials for U.S. approval of its use in coronary arteries will begin shortly, with FDA clearance expected in late 2006.

Reviewed by Gary D. Vogin, MD

    
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