FDA clears device to manage pain
NanoVibronix (Nesher, Israel) has received FDA approval for PainShield MD, a diathermy device used to treat pain. PainShield is the first hands-free, patch-based diathermy treatment. According to NanoVibronix, it offers a new dimension in ultrasound treatment of pain and soft tissue healing.
PainShield is a disposable patch connected to a portable reusable driver, which generates ultrasound waves to the desired area of the body. The device can treat tendonitis, other musculoskeletal disorders, and postoperative pain.
According to the company, the device encourages patient independence and reduces the cost of therapy by promoting clinician-supervised, home-based care.
Implantable lung valve controls air leaks
The FDA approved Spiration, Inc.'s (Redmond, Wash.) IBV Valve System, an implantable and removable valve system designed to control air leaks in the lungs that persist after certain types of lung surgery. The IBV Valve System consists of an implantable valve, a catheter for valve insertion, and a sizing kit that can be used to measure the target area for valve implantation.
The device is approved for use in patients who have undergone partial or total removal of a lung lobe or lung volume reduction surgery, and who experience prolonged air leaks or significant air leaks that may become prolonged.
The valve is inserted through a bronchoscope and placed in the airway of the lung area affected by the leak. Once inserted, the valve allows air to flow in only one direction, preventing air from entering the affected area but allowing air and mucus to escape.
Potential adverse events include pneumothorax, bleeding, bronchitis, and damage to the airway in which the valve is placed. The valve should not remain implanted for longer than 6 weeks.
Serious problemswith surgical mesh
The FDA notified healthcare practitioners of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Although rare, these complications can have serious consequences, and the agency reports that in the past 3 years it has received over 1,000 reports from nine surgical mesh manufacturers.
The mesh devices involved in the reports were usually placed transvaginally, using tools for minimally invasive placement, the FDA states. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.
Modulating device controls temperature
Cardium Therapeutics and InnerCool Therapies, Inc. (San Diego, CA) received FDA clearance to market the RapidBlue System, an endovascular temperature modulation device. This thermal regulating system is designed to manage and control patient body temperature. The new system automatically cools or warms patients as necessary to quickly achieve and maintain a desired body temperature. It works for all patient sizes and does not require any fluid introduction or exchange because it is a closed loop catheter-based system that circulates cool or warm saline within the interior of the catheter.
The system combines a high-performance programmable console with an enhanced user-friendly interface. It can quickly modulate patient core body temperature at cooling rates of 4-5[degrees] C per hour or at warming rates of 2-3[degrees] C per hour and can accurately measure core body temperature to within 0.1[degrees] C.