FDA News Leeches for Skin Healing

FDA News Leeches for Skin Healing

The FDA has approved marketing of leeches for medical purposes by Ricarimpex SAS, a French company that has been breeding the aquatic worms in a certified facility for over 150 years. According to the FDA, leeches meet the definition of a medical device under the Food, Drug, and Cosmetic Act. Leeches are used to remove pooled blood from under skin grafts and assist in healing after reattachment surgery for body parts.

Rapid HIV-2 Test

A new indication has been approved for the OraQuick Rapid HIV1/2 Antibody Test (OraSure Technologies), allowing its use for the detection of HIV-2 antibodies in oral fluid samples. The test is already approved for the detection of HIV-1 and HIV-2 antibodies in oral fluid, plasma samples, or finger stick and whole blood samples.

New Indication for Gatifloxacin

Gatifloxacin (Tequin; Bristol-Myers Squibb) has received new indication for the treatment of community-acquired pneumonia (CAP) caused by multidrug-resistant Streptococcus pneumoniae. Gatifloxacin is already approved for the treatment of CAP caused by Haemophilus influenzae, H parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila.

Cardiac Device for HF

The InSync Maximo cardiac resynchromization therapy defibrillator system (Medtronic) has been approved for the treatment of heart failure. The InSync Maximo also includes antitachycardia pacing options for ventricular tachyarrhythmias. It delivers high-output defibrillation energy and provides the shortest time between arrhythmia detection and the release of energy for defibrillation.

Imaging Agent for Appendicitis Diagnosis

Technetium fanolesomab (NeutroSpec; Palatin Technologies), an injectable imaging agent, has been approved for the scintigraphic imaging of patients with symptoms of appendicitis. Clinical trials are underway for its use in other disorders.

Da Vinci Endoscopy for CABG Surgery

The Da Vinci Endoscopic Instrument Control System (Intuitive Surgical) has been approved for use in coronary artery bypass graft surgery when a direct access to the chest via sternotomy or thoracotomy exists. The Da Vinci is already approved for several other procedures.

Smaller Implantable Drug Pump

A new implantable drug pump (SyncroMed II; Medtronic) has been approved for the treatment of chronic pain and the management of severe spasticity associated with cerebral palsy, multiple sclerosis, stroke, and brain and spinal cord injury. The 20 mL version is 30% smaller and 20% lighter than the previous model; the 40 mL version provides extended refill intervals.