Boston Scientific reported today its Q2 2020 results which show a very sharp decline in earnings due to the impact of the Covid-19 pandemic. Specifically for the active implantables industry, CRM dropped from $498M in Q2 2019 to $351M this quarter (-29.4%), and likewise neuromodulation dropped from $204M to $122M (-40%).
CVRx’s BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain FDA PMA for the BAROSTIM NEO device for improvement of symptoms in patients with heart failure.
The main results for the study were:
- BAROSTIM NEO is safe to use for patients with HFrEF, with a MANCE-free rate of 97%.
- Clinically-significant improvements in patient-centered symptomatic endpoints as compared to the control group:
- Improved quality of life score by 14.1 (p<0.001) points in MLWHFQ.
- Improved exercise capacity by 60 meters (p<0.001) as measured by the standardized 6-minute hall walk test.
- Improved functional status as assessed by NYHA classification: 65% BAROSTIM NEO versus 31% control patients experienced NYHA class improvement (p<0.001).
- Significant 25% reduction in NT-proBNP (p<0.001).
Abbott today announced that the FDA has approved its next-generation Gallant™ line of ICD and CRT-D devices. According to the announcement:
“The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.
The new Gallant system pairs with Abbott’s secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. Through the myMerlinPulse app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.”
Abbott received the CE Mark for these devices back in February 2020.