The FDA has given the green light to a device designed to help critical care doctors monitor their patients' respiratory conditions at the bedside by converting lung sounds to images.
GE Healthcare (Chalfont St. Giles, England), in partnership with Deep Breeze (Or-Akiva, Israel), a developer of vibration response imaging (VRI) technology, reported receiving FDA 510(k) clearance for the VRIxv, a non-invasive, radiation-free lung imaging system. The VRIxv was on display this week at the American Association for Respiratory Care's (AARC; Irving, Texas) 54th International Respiratory Congress in Anaheim, California.
Pam Hall, general manager for the Critical Care segment of the Respiratory and Sleep Business at GE Healthcare, told Medical Device Daily that the VRIxv system was well-received at the AARC meeting.
"The thought is that VRI is a complement to delivering care in the ICU," Hall told MDD.
Compared to the standard of care, which typically involves the physician listening to a patient's lungs with a stethoscope, Hall said the VRIxv is essentially an electronic stethoscope. So instead one person's ear gathering the data using one stethoscope, the device electronically records 20 seconds of lung sounds, typically covering several breath cycles, and converts those sounds into a visual picture of the lung function, she explained.
The process can be done at the bedside with the patient either laying flat or sitting up, Hall said.
"GE Healthcare is helping to facilitate the next era in patient care by providing to the clinical community not only a wide range of ventilation solutions, but also advanced respiratory monitoring tools such as the VRIxv, which provides a clinician with a window into what is happening inside the lungs in real time," Hall said. "Our goal is to help clinicians efficiently monitor their patients' respiratory conditions and help clinicians tailor therapy to improve the outlook for every respiratory patient."
GE said that it and Deep Breeze designed the VRIxv to display comprehensive information during the respiratory process on ventilated patients. GE said the system records lung sounds by using acoustic sensors brought in contact with the patients' back while lying in bed. Those sounds are then converted into "dynamic images" of the lungs with regional distribution maps, numerical representation and breathing graphs, the company added.
Moreover, monitoring capabilities are enhanced by synchronization of the VRIxv image and vibration energy graph, with the pressure and flow waveforms sampled from the ventilator. This synchronization helps to rapidly and objectively assess the recorded image, according to GE.
"The availability of the VRIxv device in the U.S. will allow the critical care community to effectively record and monitor the overall and regional distribution of lung sounds during the respiratory process," said R. Phillip Dellinger, MD, professor of medicine at Robert Wood Johnson Medical School and director of the Critical Care Division at Cooper University Hospital (both Camden, New Jersey). "The VRIxv provides the physician with measurements that reveal changes in lung sounds, including changes due to therapeutic treatment, changes due to ventilator settings or changes due to the clinical conditions in mechanically ventilated patients."
Founded in 2001, Deep Breeze is a private company backed by financial partners: SCP, Vitalife VC, Nisko Arden, Aviv Ventures and Union Investment Enterprise. A variety of Deep Breeze products, based on its VRI technology, have been cleared for commercialization in the U.S., Europe, China, Korea and Israel. In joint partnership with GE Healthcare, Deep Breeze introduced its critical-care device in Europe in October 2007.
Earlier this year, Deep Breeze reported that China's State Food and Drug Administration had approved the registration of its VRIxp device. Similar to the VRIxv version of the system, that device is also described as a non-invasive, radiation-free imaging system that creates dynamic functional imaging of the lungs. The VRIxp was approved by SFDA to help doctors diagnose and manage patients suffering from respiratory complaints (Medical Device Daily, March 17, 2008). The company also reported last year that the VRIxp system was available in the U.S. (MDD, Oct. 24, 2007).
"The FDA clearance of VRIxv advances our efforts to create a new clinical paradigm in which our VRI technology will be the standard application in a broad line of clinical applications, such as monitoring the impact of ventilator settings or managing risk associated with mechanically ventilated patients." said Miki Nagler, CEO of Deep Breeze.