Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia. Final order.

The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device. Final order.

The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Crioterapia laparoscópica retroperitoneal en tumor renal sincrónico bilateral / Retroperitoneal laparoscopic cryotherapy in bilateral, synchronous kidney tumor

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Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule.

The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.

Proliferaçäo vítreo-retiniana após retinopexia: influência da crioterapia / Proliferative vitreoretinopathy: the influence of cryoterapy

Foram analisados, de forma retrospectiva, 136 pacientes com descolamento da retina provocado por ruptura única, ou múltipla, pequena(s), localizada(s) no hemisfério retiniano superior, sem retinopatia vítreo-proliferativa pré-operatória (RVP), operados por pneumo-retinopexia (RP) ou introflexäo escleral setorial (IE), com crio ou laser no tratamento térmico das rupturas. O objetivo foi o de analisar a possível influência da crioterapia na gênese do PVR pós-operatório. Grupo I consistiu de 36 olhos operados por RP + laser; Grupo 2, 34 olhos, RP + crio; Grupo 3, 40 olhos, IE + laser; e Grupo 4, 25 olhos, IE + crio. O número de afácicos, a faixa etária, o número de quadrantes descolado, a acuidade pré-operatória e o tempo de seguimento foram semelhantes

Cryotherapy in sports medicine.

The use of cryotherapy, i.e. the application of cold for the treatment of injury or disease, is widespread in sports medicine today. It is an established method when treating acute soft tissue injuries, but there is a discrepancy between the scientific basis for cryotherapy and clinical studies. Various methods such as ice packs, ice towels, ice massage, gel packs, refrigerant gases and inflatable splints can be used. Cold is also used to reduce the recovery time as part of the rehabilitation programme both after acute injuries and in the treatment of chronic injuries. Cryotherapy has also been shown to reduce pain effectively in the post-operative period after reconstructive surgery of the joints. Both superficial and deep temperature changes depend on the method of application, initial temperature and application time. The physiological and biological effects are due to the reduction in temperature in the various tissues, together with the neuromuscular action and relaxation of the muscles produced by the application of cold. Cold increases the pain threshold, the viscosity and the plastic deformation of the tissues but decreases the motor performance. The application of cold has also been found to decrease the inflammatory reaction in an experimental situation. Cold appears to be effective and harmless and few complications or side-effects after the use of cold therapy are reported. Prolonged application at very low temperatures should, however, be avoided as this may cause serious side-effects, such as frost-bite and nerve injuries. Practical applications, indications and contraindications are discussed.