FDA strengthens its Cryotherapy for COPD

Diving Brief:

• The FDA has badigned the designation of a revolutionary device to a cryotherapy spray designed for the subgroup of patients with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis, CSA Medical, a medical technology manufacturer based in Lexington, Mbad., Announced Wednesday.
• The company claims that its RejuvenAir system vaporizes liquid nitrogen at -196 degrees Celsius to rapidly freeze the epithelial lining of the airway walls, destroying goblet cells that produce mucus while preserving extracellular matrix that can regenerate healthy cells.
• CSA Medical also stated that the FDA had granted an unrestricted exemption for experimental devices, which allowed it to go forward with a pivotal study.

Insight on diving:

The adoption of cryoablation devices, intended to destroy unwanted tissues by application of extreme cold, has spread to areas affected by the disease.

Stryker acquired a startup Arrinex earlier this year, including Clarifix This tool offers a cryotherapy option for people with chronic rhinitis. Medtronic is one of those who follow the method in patients with atrial fibrillation, seeking to eliminate cells that send erratic electrical signals. With the complete acquisition of BTG, Boston Scientific would obtain Galil Medical's range of cryoablation and needle systems for targeting solid tumors, as broad technology is gaining more and more ground as a treatment option viable for the bones, cervix, eyes, kidneys. liver, lung and prostate cancers.

Earlier this week, the FDA approved the LDCs treatment request administered in a gynecologist's office for premenopausal women with heavy menstrual bleeding, in which a freezing agent blocks the endometrial lining of the uterine cavity. In particular, the treatment does not require any sedation.

The introduction of cryoablation procedures in the main treatment of patients with chronic bronchitis would be new. With 8.6 million US diagnoses in the last year alone, chronic bronchitis is the most common disease among COPD patients, which can not be cured. Inflamed bronchial tubes result in significant mucus production, prolonged cough, and in some cases fatigue, shortness of breath, and fever that can be treated with medication, oxygen therapy, or other drugs. Surgical excision of damaged lung tissue.

CSA Medical completed its feasibility study last year and announced in a press release that it is now considering conducting a randomized, simulacrum-controlled trial at 30 sites in the US, Europe and Canada. , with a maximum of 330 patients. Initial small-scale safety data was published in the American Journal of Respiratory and Critical Care Medicine in 2017.

CSA Medical is already marketing its truFreeze vaporizer kit for patients with acid reflux, oesophogeal cancer and other conditions.

The recently announced revolutionary features include an automated closed loop insulin delivery system developed by a Korean biotech and Fresenius Medical Care hemodialysis management software.