Essential Medical

Essential Medical, Inc. was a medical device company established in 2010, specializing in vascular closure solutions for femoral artery punctures following interventional cardiac procedures. The company was the result of a collaboration between Greg Walters, a product development executive with deep experience in cardiovascular devices, and Dr. Gary Roubin, MD, PhD, an internationally recognized interventional cardiologist known for his pioneering work in coronary and carotid stenting. Walters' background in engineering and management, combined with Dr. Roubin's extensive clinical expertise and history of innovation in cardiology, provided a strong foundation for addressing unmet needs in catheterization laboratories.

The company's core focus was the development and commercialization of devices to seal large bore access sites, a growing challenge driven by the increasing popularity of procedures like transcatheter aortic valve replacement (TAVR) and endovascular aneurysm repair (EVAR). Essential Medical's flagship product was the MANTA™ Vascular Closure Device. This device was engineered to provide rapid and reliable hemostasis for large bore femoral arteriotomies, specifically for sheaths ranging from 10F to 18F. The MANTA device utilizes a unique biomechanical approach, deploying a toggle and a resorbable collagen plug to create a secure seal at the puncture site. This design aimed to significantly reduce the time to hemostasis and lower complication rates compared to manual compression or suture-based methods. Clinical studies demonstrated its effectiveness, showing a median time to hemostasis of about one minute.

Essential Medical achieved significant milestones, including securing a CE Mark for the MANTA device in July 2016, which allowed for its commercialization across numerous European countries. Following successful European adoption with over 8,100 procedures performed, the company received Investigational Device Exemption (IDE) approval from the FDA in 2016 to begin pivotal clinical trials in the United States. The company's trajectory culminated in its acquisition by Teleflex Incorporated in October 2018. The acquisition was valued at $160 million, consisting of an upfront cash payment and potential milestone payments. Post-acquisition, Teleflex successfully obtained FDA premarket approval for the MANTA device in February 2019, solidifying its position in the interventional cardiology market.

Keywords: vascular closure device, femoral artery closure, large bore access, interventional cardiology, MANTA device, cardiac catheterization, hemostasis, Teleflex, Greg Walters, Gary Roubin, TAVR closure, EVAR closure, arteriotomy closure, percutaneous closure, resorbable collagen plug, medical device, cardiovascular, structural heart, endovascular repair, PFO closure