BOX 7-1

Examples of Devices Approved Under the Humanitarian Device Exemption

The Spiration IBV is indicated to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery. An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is (1) continuous, (2) present during normal inhalation phase of inspiration, or (3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Approved October 24, 2008 (H060002).

TAS Ecarin Clotting Time Test is used to determine the anticoagulant effect of recombinant hirudin (r-hirudin) during cardiopulmonary bypass in patients who have heparin-induced thrombocytopenia. Approved May 11, 2000 (H990012).

Epicel (cultured epidermal autografts) is for use with patients who have deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30 percent. It may be used in conjunction with split-thickness autografts or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. Approved October 25, 2007 (H990002).

DeBakey VAD Child Left Ventricular Assist System is to provide temporary left-side mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients (5-16 years old, with BSA ≥ 0.7 m2 and <1.5 m2) who are in NYHA Class IV end-stage heart failure, are refractory to medical therapy, and are (listed) candidates for cardiac transplantation. Approved February 25, 2004 (H030003).

Abiocor Implantable Replacement Heart is indicated for use in severe biventricular end-stage heart disease patients who are not cardiac transplant candidates and who are less than 75 years old, require multiple inotropic support, are not treatable by left ventricular assist device (LVAD) destination therapy, and are not weanable from biventricular support if on such support. Approved September 5, 2006 (H040006).

Activa Dystonia Therapy is for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug-refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years of age or older. Approved April 15, 2003 (H020007).

SOURCE: FDA listing of CDRH Humanitarian Device Exemptions. HDE approval numbers are in parentheses.

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