Drug-Resistant Hypertension Clinical Trials
Vascular Dynamics has sponsored the CALM (Controlling And Lowering blood pressure with MobiusHD) clinical hypertension studies.
CALM-2 Pivotal Trial
The CALM-2 study protocol was developed based on learnings from numerous clinical trials of device-based approaches to hypertension over the past ten years and provides a rigorous clnical trial design. The CALM-2 trial will comprehensively assess the safety and effectiveness of the MobiusHD device in patients with resistant hypertension. CALM-2 is a prospective, randomized multi-center, sham-controlled, double-blind FDA-approved pivotal clinical trial.
The CALM-2 clinical trial is currently enrolling at select medical centers in the United States and Europe. For more information visit www.calm2study.comSee if you qualify
The novel EVBA procedure using the MobiusHD® device was evaluated in the FDA-approved proof-of-concept CALM-FIM study. CALM-FIM was a prospective, open label study of 47 patients with resistant hypertension.
Thirty patients in Europe and seventeen in the United States were included in the study. Enrolled patients had resistant hypertension despite being on stable maximally tolerated doses of three or more anti-hypertensive agents including a diuretic. Patients with plaque or ulceration of the carotid artery or aortic arch were excluded. Study patients had a mean ambulatory blood pressure measurement (ABPM) of 166/98 mmHg and were on medication regimens averaging 4.5 anti-hypertensive drugs.
The MobiusHD device was successfully implanted in all 47 study patients in the CALM-FIM trial. Mean ABPM measurements showed significant reductions of 15 mmHg and 20 mmHg at three and six months, respectively. There were no unexpected adverse device events. Results of the European cohort have been published (Spiering et al., Lancet, 2017). Feasibility study results show that EVBA with the MobiusHD device has an acceptable safety profile appropriate for further clinical investigation.