Business Wire02.18.20
Cardiva Medical Inc., an innovator in the field of vascular closure, has appointed medical device expert Jeryl (Jeri) Hilleman to the company’s Board of Directors.
“We are thrilled to welcome Jeri to our team and look forward to leveraging her deep expertise with high-growth medical device companies and in building global markets for technologies,” said John Russell, president and CEO of Cardiva Medical Inc. “We believe that Jeri’s dynamic experience will help strengthen our position as a leader in vessel closure for coronary, peripheral and electrophysiology procedures as we continue to accelerate Cardiva’s exciting growth.”
Hilleman currently serves on the board of directors and as audit committee chair of Novocure, Minerva, and SI-Bone. She most recently served as chief financial officer of Intersect ENT.
“Cardiva Medical has emerged as a leader in vascular closure,” said Hilleman. “I look forward to working with the Cardiva Board and leadership team to expand the reach of Cardiva’s portfolio of vascular closure devices to even more patients, physicians and health systems.”
The Company’s VASCADE vascular closure system has been PMA-approved by the U.S. Food and Drug Administration since 2013 and is indicated for vessel closure following 5-7F arterial and venous procedures. VASCADE is the only marketed closure system to demonstrate a statistically significant reduction in access site complications compared to the existing standard of care in a prospective, randomized, controlled clinical trial called RESPECT. The latest product in the company’s portfolio is VASCADE MVP Venous Vascular Closure System, the only marketed vessel closure technology designed specifically for Electrophysiology procedures and clinically proven by Electrophysiology physicians in a multi-center, randomized, controlled clinical trial called AMBULATE. VASCADE MVP received PMA approval in late 2018.
Last fall, Cardiva Medical announced positive results from the AMBULATE pivotal study demonstrating the safety and efficacy of the company’s VASCADE MVP Venous Vascular Closure System compared to manual compression. The company also received CE Mark certification in Europe for VASCADE MVP. In both the United States and Europe, VASCADE MVP is now the first and only vascular closure system designed and labeled specifically for multi-site venous closure following electrophysiology procedures.
The AMBULATE pivotal study is a randomized, controlled study of 204 patients across 13 sites treated with the VASCADE MVP System compared to standard manual compression following cardiac ablation. The study showed significant improvements in time to ambulation, total post-procedure time and time-to-discharge eligibility, as well as improved patient satisfaction scores and significantly reduced use of opioid pain medications. Principal investigators and authors of the study include Andrea Natale, M.D., of the Texas Cardiac Arrhythmia Institute; Mintu Turakhia, M.D., associate professor at Stanford University School of Medicine; and Steve Compton, M.D., of the Alaska Heart and Vascular Institute.
Cardiva Medical Inc. is a privately held medical device company focused on transforming vascular closure for the benefit of patients, hospitals and physicians in the more than 5.5 million catheter-based coronary, peripheral and electrophysiology procedures in the United States that require access site closure each year.
“We are thrilled to welcome Jeri to our team and look forward to leveraging her deep expertise with high-growth medical device companies and in building global markets for technologies,” said John Russell, president and CEO of Cardiva Medical Inc. “We believe that Jeri’s dynamic experience will help strengthen our position as a leader in vessel closure for coronary, peripheral and electrophysiology procedures as we continue to accelerate Cardiva’s exciting growth.”
Hilleman currently serves on the board of directors and as audit committee chair of Novocure, Minerva, and SI-Bone. She most recently served as chief financial officer of Intersect ENT.
“Cardiva Medical has emerged as a leader in vascular closure,” said Hilleman. “I look forward to working with the Cardiva Board and leadership team to expand the reach of Cardiva’s portfolio of vascular closure devices to even more patients, physicians and health systems.”
The Company’s VASCADE vascular closure system has been PMA-approved by the U.S. Food and Drug Administration since 2013 and is indicated for vessel closure following 5-7F arterial and venous procedures. VASCADE is the only marketed closure system to demonstrate a statistically significant reduction in access site complications compared to the existing standard of care in a prospective, randomized, controlled clinical trial called RESPECT. The latest product in the company’s portfolio is VASCADE MVP Venous Vascular Closure System, the only marketed vessel closure technology designed specifically for Electrophysiology procedures and clinically proven by Electrophysiology physicians in a multi-center, randomized, controlled clinical trial called AMBULATE. VASCADE MVP received PMA approval in late 2018.
Last fall, Cardiva Medical announced positive results from the AMBULATE pivotal study demonstrating the safety and efficacy of the company’s VASCADE MVP Venous Vascular Closure System compared to manual compression. The company also received CE Mark certification in Europe for VASCADE MVP. In both the United States and Europe, VASCADE MVP is now the first and only vascular closure system designed and labeled specifically for multi-site venous closure following electrophysiology procedures.
The AMBULATE pivotal study is a randomized, controlled study of 204 patients across 13 sites treated with the VASCADE MVP System compared to standard manual compression following cardiac ablation. The study showed significant improvements in time to ambulation, total post-procedure time and time-to-discharge eligibility, as well as improved patient satisfaction scores and significantly reduced use of opioid pain medications. Principal investigators and authors of the study include Andrea Natale, M.D., of the Texas Cardiac Arrhythmia Institute; Mintu Turakhia, M.D., associate professor at Stanford University School of Medicine; and Steve Compton, M.D., of the Alaska Heart and Vascular Institute.
Cardiva Medical Inc. is a privately held medical device company focused on transforming vascular closure for the benefit of patients, hospitals and physicians in the more than 5.5 million catheter-based coronary, peripheral and electrophysiology procedures in the United States that require access site closure each year.