Amavita Heart and Vascular Partners with LimFlow for CLTI Treatment
Key Insights
Dr. Pedro Martinez-Clark partners with LimFlow (search) to offer a minimally invasive solution for chronic limb-threatening ischemia (search) (CLTI) patients.
The LimFlow (search) System, recently FDA-approved, aims to restore blood flow, heal wounds, and prevent amputations in 'no-option' CLTI patients.
Clinical trial data showed a 76% amputation avoidance rate with the LimFlow (search) System, offering significant wound healing and pain relief.
Dr. Pedro Martinez-Clark, founder of Amavita Heart and Vascular (search), is partnering with LimFlow (search) to provide a novel treatment option for patients with chronic limb-threatening ischemia (search) (CLTI). This collaboration follows the FDA approval of the LimFlow System, a minimally invasive therapy designed to prevent major amputations in patients who have exhausted other revascularization options.
Addressing Critical Limb Ischemia
CLTI, the most severe form of peripheral artery disease (search) (PAD), affects millions in the U.S., causing reduced blood flow to the extremities, chronic pain, non-healing wounds, and often, amputation. The LimFlow (search) System offers a new approach through transcatheter arterialization of deep veins (TADV), re-establishing blood flow in deep veins to facilitate wound healing, reduce pain, and prevent limb loss. It stands as the first and only FDA-approved TADV system.
"As a physician dedicated to treating PAD and preventing amputations, I am excited to partner with LimFlow (search) and bring this groundbreaking technology to my patients," said Dr. Pedro Martinez-Clark. "Many of the individuals who suffer from CLTI are underserved and have no remaining options, facing the life-changing reality of amputation. With the LimFlow System, we can restore blood flow to their limbs, dramatically improving their prognosis and overall quality of life."
Clinical Evidence and FDA Approval
The FDA's approval was based on the PROMISE II pivotal trial, which demonstrated that 76% of "no-option" CLTI patients avoided amputation and experienced significant wound healing and pain relief. This data underscores the potential of the LimFlow (search) System to transform the treatment landscape for advanced CLTI cases.
Expanding Access and Improving Outcomes
"We are thrilled to have Dr. Martinez-Clark join us in our mission to provide life-saving treatments for patients at risk of limb loss," said Dan Rose, CEO of LimFlow (search). "Dr. Martinez-Clark's expertise in PAD treatment and his commitment to underserved communities perfectly align with LimFlow's goal of expanding access to this innovative procedure, giving hope to patients who previously had none."
Amavita's Commitment to Cardiovascular Care
Dr. Martinez-Clark founded Amavita Heart and Vascular (search) in 2017, specializing in minimally invasive cardiovascular treatments. Through the Amavita Foundation, he also launched the Miami Initiative to Stop Amputations (MISA), aiming to reduce non-traumatic lower extremity amputations in Miami-Dade County by 20% over the next decade through education and early intervention.
With state-of-the-art facilities, Amavita offers comprehensive cardiovascular care, including treatments for coronary artery disease, arrhythmias, and chronic venous insufficiency. The integration of the LimFlow (search) System further solidifies Amavita's position as a leader in combating PAD and CLTI.