Business Wire03.06.19
Vascular Dynamics Inc., a privately held medical device company focused on minimally invasive device-based solutions for cardiovascular conditions, has appointed Martin T. Rothman FRCP, FACC, FESC as chief medical officer.
Rothman is a world-renowned pioneer in interventional cardiology, as evidenced by his clinical practice spanning several decades, his extensive pre-clinical and clinical research presented in over 200 publications, his success within the cardiovascular industry as a founder of several startup companies, and his leadership roles at Medtronic.
Recently, Rothman was chief medical officer and vice president of Medical Affairs for the Coronary, Structural Heart, and Renal Denervation Division at Medtronic plc. In this role, he was involved in evidence development strategies and guided new product development teams for a wide indication spectrum including coronary and vascular disease, resistant hypertension, and minimally invasive and percutaneous mitral valve replacement and repair. Also, following the announcement of the failed HTN-3 study, he was instrumental in the interpretation of renal denervation data and working with others on new strategies for the development of RDN as a treatment option for hypertension patients.
“Prof. Rothman’s extraordinary background and experience bring tremendous value to our company as he assumes responsibilities in this new position,” said Ed Roschak, president and CEO of VDI. “He will immediately advance our ability to execute our recently-initiated pivotal clinical study and to develop the portfolio of evidence necessary to support FDA approval and ultimate commercialization of a safe and effective therapy. While our initial focus is on those struggling with uncontrolled hypertension, we also look forward to Prof. Rothman’s leadership as we explore potential solutions to additional cardiovascular conditions.“
“As a clinician, researcher, and industry participant, I have followed closely the development and initial positive clinical evidence reported for the EVBA approach using the MobiusHD device,” said Rothman. “I am excited about its potential as a viable treatment option for the many patients facing the dire prognoses of resistant hypertension and the potential in other unmet cardiovascular challenges. I look forward to being a part of the VDI team as we advance new breakthrough solutions for these patients.”
VDI is currently sponsoring the CALM-2 (Controlling And Lowering blood pressure with MobiusHD) clinical trial, designed to establish the safety and efficacy of the novel endovascular baroreceptor amplification (EVBA) procedure using the unique MobiusHD device as a treatment for drug-resistant hypertension.
MobiusHD is the first minimally invasive technology to use the body’s natural baroreceptor mechanism of regulating blood pressure to address uncontrolled hypertension. Early results of the proof-of-concept CALM-FIM trial are promising, with reductions in blood pressure through six months that were significant and greater than those reported to date for alternative devices used to treat uncontrolled hypertension. These results, combined with lessons learned in previous clinical trials of device-based approaches, led to the CALM2 study, which began in the second half of 2018.
Vascular Dynamics develops minimally invasive platform technologies to treat patients at risk of life-threatening cardiovascular events and underserved by conventional treatments. Focused initially on uncontrolled hypertension, VDI was approved to participate in the U.S. Food and Drug Administration's Expedited Access Pathway (EAP) program. EVBA treatment with the MobiusHD implant system has received a CE Mark for the treatment of hypertension in the European Union. However, the MobiusHD system is not commercially available in the United States. In the United States, the MobiusHD device is limited by law to investigational use only.
Rothman is a world-renowned pioneer in interventional cardiology, as evidenced by his clinical practice spanning several decades, his extensive pre-clinical and clinical research presented in over 200 publications, his success within the cardiovascular industry as a founder of several startup companies, and his leadership roles at Medtronic.
Recently, Rothman was chief medical officer and vice president of Medical Affairs for the Coronary, Structural Heart, and Renal Denervation Division at Medtronic plc. In this role, he was involved in evidence development strategies and guided new product development teams for a wide indication spectrum including coronary and vascular disease, resistant hypertension, and minimally invasive and percutaneous mitral valve replacement and repair. Also, following the announcement of the failed HTN-3 study, he was instrumental in the interpretation of renal denervation data and working with others on new strategies for the development of RDN as a treatment option for hypertension patients.
“Prof. Rothman’s extraordinary background and experience bring tremendous value to our company as he assumes responsibilities in this new position,” said Ed Roschak, president and CEO of VDI. “He will immediately advance our ability to execute our recently-initiated pivotal clinical study and to develop the portfolio of evidence necessary to support FDA approval and ultimate commercialization of a safe and effective therapy. While our initial focus is on those struggling with uncontrolled hypertension, we also look forward to Prof. Rothman’s leadership as we explore potential solutions to additional cardiovascular conditions.“
“As a clinician, researcher, and industry participant, I have followed closely the development and initial positive clinical evidence reported for the EVBA approach using the MobiusHD device,” said Rothman. “I am excited about its potential as a viable treatment option for the many patients facing the dire prognoses of resistant hypertension and the potential in other unmet cardiovascular challenges. I look forward to being a part of the VDI team as we advance new breakthrough solutions for these patients.”
VDI is currently sponsoring the CALM-2 (Controlling And Lowering blood pressure with MobiusHD) clinical trial, designed to establish the safety and efficacy of the novel endovascular baroreceptor amplification (EVBA) procedure using the unique MobiusHD device as a treatment for drug-resistant hypertension.
MobiusHD is the first minimally invasive technology to use the body’s natural baroreceptor mechanism of regulating blood pressure to address uncontrolled hypertension. Early results of the proof-of-concept CALM-FIM trial are promising, with reductions in blood pressure through six months that were significant and greater than those reported to date for alternative devices used to treat uncontrolled hypertension. These results, combined with lessons learned in previous clinical trials of device-based approaches, led to the CALM2 study, which began in the second half of 2018.
Vascular Dynamics develops minimally invasive platform technologies to treat patients at risk of life-threatening cardiovascular events and underserved by conventional treatments. Focused initially on uncontrolled hypertension, VDI was approved to participate in the U.S. Food and Drug Administration's Expedited Access Pathway (EAP) program. EVBA treatment with the MobiusHD implant system has received a CE Mark for the treatment of hypertension in the European Union. However, the MobiusHD system is not commercially available in the United States. In the United States, the MobiusHD device is limited by law to investigational use only.
