The CARDIOMEMS HF system is indicated for the wireless measurement and monitoring of pulmonary artery pressure in patients with heart failure NYHA (NEWYORK HEART ASSOCIATION) class III who have been hospitalized for heart failure during the previous year. The hemodynamic data allow doctors to treat heart failure and reduce hospitalizations for this condition. The doctor can use the CARARDOMS HF system in the hospital or the office to perform pulmonary blood pressure measurements and analyze them. The patient can use the CARDIOMEMS HF system in his home to make and send hemodynamic measurements and pulmonary arterial depression wirelessly to a secure database for analysis and evaluation by the physician.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.