Aquedeon Medical | Top Emerging Cardio Vascular Device Company 2021

MedTech Outlook Magazine

Aquedeon Medical
A NewGeneration of Cardiothoracic Graft Anastomoses

Tom Palermo, Co-Founder, Aquedeon MedicalTom Palermo, Co-Founder
When a patient is diagnosed with a life-threatening tearingof the aorta’s layers, the immediate course of action is emergency surgery. To access the effected anatomy,this open surgery requires what is calledhypothermic circulatory arrest (HCA).HCA is a standard of care in which very cold body temperaturescan be used for up to 40 minutes to limit cerebral metabolism, thus providing neuroprotection for the patient. Under HCA, thesurgeon has a limited timeframe to identify the damage and to surgically reconstructthe aorta and effected blood vessels. To create a reliable path for blood flow, portions of the damaged aorta and vessels are replaced with synthetic graft(s) offered from a variety of manufacturers.The overall surgery lasts around four to six hours, and within that time there exists an upper limit to the required HCA to safeguard against brain damage. Therefore, these procedures are complex and high-pressure. According to Grayson Wheatley, MD of TriStar Medical Group in Nashville, TN, “We as surgeons must work quickly to determine the location of the tears, choose the most appropriate approach, and get the patient into the OR. A matter of minutes can save lives.”

Aquedeon Medical’s mission is to reduce the underlying HCA time associated with reconstruction of the aorta and effected blood vessels. After only three years since its inception, Aquedeon Medical has demonstrated strong progress in the development of a very intriguing technology. The company’s Duett Vascular Graft System is designed as a modular solution to rapidly connect a patient’s native vessel to a synthetic one.According to Bilal Shafi, MD of Sutter Health in Santa Cruz, CA, “Using an anastomoses device that connects a surgical graft to an artery could reduce the risk associated with HCA time, potentially protecting the brain from injury.”

A matter of minutes can save lives


Aquedeon Medical’s team of medical professionalsmaintain a comprehensive understanding of the importance and significance of creating technologies that drive consistency. Wilson Szeto, MD of Penn Medicine in Philadelphia, PA stated, “Any time we (surgeons) can make something more reproducible, we hope the conduct of operation and ultimately the outcomes can have less variation and be improved.” The elegance of Aquedeon Medical’s solution is that it does not change the surgical procedure, instead it augments the surgeon’s processes related to connecting vessels to grafts (anastomoses). Faraz Kerendi, MD of Cardiothoracic and Vascular Surgery in Austin, TX stated, “An anastomoses device that can adapt to the variations of the patient’s vasculature and surgeon’s technique preferences is beneficial”.

“Our device performs like a self-expanding connector, which helps connect the patients’ vessels to syntheticbranch grafts,typically in four minutes or less per vessel,” statedTom Palermo, co-founder and COO of Aquedeon Medical. The company’s Duett Vascular Graft System enables suture-less anastomoses - the system consists of a specialized Delivery System and a preloaded self-expanding Duett Vascular Graft. The DeliverySystem has a dual action slider. The first activation of the slider deploys the Duett Vascular Graft within the patient’s native vessel.The second deployment of the slider completes the anastomosis to the required graft.

Aquedeon Medical works through strong collaborations with renowned cardiothoracic surgeons, solving problems they routinely encounter. After recently exiting stealth mode, Aquedeon Medical looks to continue moving forward with its technology development. “There is an opportunity to enhance surgery by reducing HCA time associated with aortic reconstruction”, stated Timothy Buckley Vice President of Marketing. He continued, “if our technology can help a surgeon save even one extra life, it will all be worthwhile.”

Top 10 Emerging Cardio Vascular Device Companies - 2021

Company
Aquedeon Medical

Management
Tom Palermo, Co-Founder

Description
Aquedeon Medical was founded with the mission of reducing circulatory arrest time during open cardiothoracic surgery.The company’s Duett Vascular Graft System is designed as a modular solution to rapidly connect a patient’s native vessel to a synthetic one. It enables suture-less anastomoses - the system consists of a specialized Delivery System and a preloaded self-expanding Duett Vascular Graft. The Delivery System has a dual action slider. The first activation of the slider deploys the Duett Vascular Graft within the patient’s native vessel.The second deployment of the slider completes the anastomosis to the required graft

Aquedeon Medical News

Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System

SUNNYVALE - Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. The study will be initiated in the second half of 2023, enrolling up to 20 patients at up to 5 clinical sites for the first stage of the trial.
Surgical intervention for thoracic aortic conditions like aneurysms and dissections involves intricate and time-consuming processes. Treating these conditions through open surgical thoracic aortic repair typically requires several hours of complex procedures. One aspect of this procedure involves spending around 30-45 minutes to perform anastomoses, where the surgeon attaches each individual native branch vessel to the surgical graft using sutures. This prolonged suturing time not only extends the duration of cardiopulmonary bypass and deep hypothermic circulatory arrest (DHCA), but also elevates the potential risk of complications that patients undergoing this treatment might face.
To address these challenges, the Duett Vascular Graft System was innovatively developed. This system aims to streamline and standardize open surgical thoracic aortic procedures, providing cardiothoracic surgeons with an efficient method to manage target vessels. Functioning as a vascular connector, it facilitates the connection between native aortic arch branch vessels and the surgical graft without necessitating complete circumferential suturing for each anastomosis. This innovation has the potential to reduce DHCA time and overall procedure duration.
"The introduction of the Duett Vascular Graft System signifies another addition to the array of tools available to surgeons in the surgical treatment of aortic arch pathology", said Dr. Wilson Szeto, Chief of Cardiovascular Surgery at Penn Presbyterian Medical Center, Philadelphia, PA and Professor of Surgery at the University of Pennsylvania School of Medicine, who is serving as the Principal Investigator for the clinical trial. Dr. Szeto also highlighted his longstanding involvement with the Duett Vascular Graft System's evolution, since the company's inception, and expressed enthusiasm about participating in the imminent clinical trial.
"The Duett Vascular Graft System has been developed in collaboration with leading cardiothoracic surgeon and the device is aimed at helping to address the complexities and intricacies of thoracic aortic surgeries. Reducing anastomosis time is one major step in addressing this long and complex procedure." "We acknowledge FDA's dedication during the IDE review process and we will continue to work closely with the agency throughout the study with a mission to put this innovative device into the hands of surgeons", said Tom Palermo, Chief Operating Officer of Aquedeon Medical.