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CardiacVascular News: Saranas Announces Peer-Reviewed Publications Highlighting Accuracy and Clinical Utility of Early Bird® Bleed Monitoring System
Saranas, Inc., developer of the Early Bird® Bleed Monitoring System for the monitoring and early detection of internal bleed complications during endovascular procedures, announced the online publication of two peer-reviewed articles highlighting the system’s accuracy and performance. The publications provide evidence of the Early Bird’s reliability to detect the early onset and progression of bleeding events during endovascular procedures.
Saranas Announces Peer-Reviewed Publications Highlighting Accuracy and Clinical Utility of Early Bird® Bleed Monitoring System
Houston, TX — Saranas, Inc., developer of the Early Bird® Bleed Monitoring System for the monitoring and early detection of internal bleed complications during endovascular procedures, announced the online publication of two peer-reviewed articles highlighting the system’s accuracy and performance. The publications provide evidence of the Early Bird’s reliability to detect the early onset and progression of bleeding events during endovascular procedures.
One paper, entitled “Safety and Accuracy of a Novel Bioimpedance System for Real-Time Detection and Monitoring of Endovascular Procedure-Related Bleeding in a Porcine Model,” was published online in the Journal of Invasive Cardiology (https://bit.ly/2XK0qj8). The paper contains results from the study, which evaluated the performance of the Early Bird to detect endovascular bleeding through a validated animal bleed model. The study concluded that the Early Bird could detect the onset and progression of bleeds with 100% sensitivity as well as 100% specificity.
A second paper, entitled “First-in-Human Study of the Saranas Early Bird® Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events,” was published online in the Journal of Invasive Cardiology (https://bit.ly/2AdKEEh). The Early Bird was used during and after endovascular procedures in 60 patients across 5 centers in the United States. The primary endpoint was the level of agreement in bleeding detection between the Saranas Early Bird and post-procedural computed tomography (CT). The clinical study results validate the effectiveness of the Early Bird with a high level of agreement (Cohen’s kappa=0.84) when compared to independently reviewed post-procedural CT scans.
“Among a population of all-comer patients undergoing a broad variety of endovascular procedures, the Early Bird was safe, easily incorporated into our standard workflow, and demonstrated the capacity to detect bleeding before the progression to a more severe or symptomatic phase,” said Philippe Généreux, MD (Morristown Medical Center, NJ), the study’s primary author.
“These two published studies underscore our commitment to conducting rigorous scientific and clinical studies that demonstrates the value and utility of the Early Bird Bleed Monitoring System,” said Saranas President and CEO James Reinstein. “As the first and only device on the market for early bleed detection, the Early Bird has the potential to significantly reduce the severity of bleeding complications and resulting costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
About the Early Bird Bleed Monitoring System
The Early Bird Bleed Monitoring System includes a Bleed Detection Array with integrated electrodes in a fully functional vascular access sheath. The Early Bird is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events.
About Saranas
Saranas is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company’s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs. For more information, please visit www.saranas.com.
Contact Information
Investor Relations
Saranas, Inc.
713-357-1049
[email protected]
Saranas Announces Peer-Reviewed Publications Highlighting Accuracy and Clinical Utility of Early Bird® Bleed Monitoring System
Saranas, Inc., developer of the Early Bird® Bleed Monitoring System for the monitoring and early detection of internal bleed complications during endovascular procedures, announced the online publication of two peer-reviewed articles highlighting the system’s accuracy and performance.
First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events
Safety and Accuracy of a Novel Bioimpedance System for Real-Time Detection and Monitoring of Endovascular Procedure-Related Bleeding in a Porcine Model
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Saranas Launches Early Bird® Bleed Monitoring System in the U.S.
Saranas, Inc. today announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors.
Saranas Launches Early Bird® Bleed Monitoring System in the U.S.
HOUSTON–(BUSINESS WIRE)–Saranas, Inc. today announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors. Saranas will demonstrate the device in Booth 1755 at the Transcatheter Cardiovascular Therapeutics (TCT) Conference being held September 25 – 29, 2019, at the Moscone Center in San Fransicso, CA.
One in five patients experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR) and percutaneous hemodynamic support. This complication is associated with a three times increase in mortality, two times increase in length of hospital stay and 60 percent increase in healthcare costs, according to a 2017 report in the Journal of the America Medical Association.
“As the first and only early bleed detection system on the market, the Early Bird is ideally positioned to play a key role in making the rapidly expanding, minimally-invasive catheter-based procedures safer by providing physicians with bleed monitoring in real-time,” said Saranas President and CEO Zaffer Syed. “With the launch of the Early Bird, physicians will now have a standard of care to monitor the bleed status of the patient during and post procedure, receive timely notifications of actual bleeds, and potentially reduce the severity of bleeding complications and resulting costs, while protecting clinical outcomes in patients undergoing endovascular procedures.”
Saranas was granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird in March of this year. The company presented first-in-human results in May 2019 at the Society for Cardiovascular Angiography Interventions (SCAI), demonstrating that the Early Bird Bleed Monitoring System is safe, easily incorporated into standard workflows and able to detect bleeding before progression to a more severe or symptomatic phase.
“Our first-in-human study demonstrated that clinical concordance with Early Bird detection and CT scans (primary endpoint) was near perfect, and the early discovery of bleed onset and progression during the procedure occurred in 31 percent of cases with 69 percent occurring post procedure,” stated Saranas Chief Medical Officer Dr. Philippe Généreux. “Compared to the current paradigm of waiting for symptoms, which could take hours to develop, the Early Bird allows physicians to detect bleeding in real-time and take the necessary actions quickly to protect the outcomes of the procedure and aid recovery for the patient.”
Concurrent with the launch, industry veteran Tom Lucas joins Saranas as Vice President, Sales and Marketing. He brings 28 years medical sales experience and leadership, including strategic market development roles with Cook Medical and Circadiance. Lucas will direct and oversee all aspects of commercial sales, business development, marketing, strategic alliances and distributor relationship management.
“Tom is a critical strategic hire for Saranas as we launch our first product in the U.S.,” said Saranas President and CEO Zaffer Syed. “His expertise will be invaluable as we expand distribution of the Early Bird into additional centers of excellence.”
Initial clinical experience with the Early Bird and its potential role in protecting outcomes with real-time bleed monitoring will be reviewed at the following TCT presentation:
- Friday, September 27, 2019, @ 6:45am during Breakfast Satellite Program:
- “Optimization of Vessel Access and Closure in Large Bore Catheter Procedures: Tips and Tricks Case-Based Review”
About the Early Bird Bleed Monitoring System
The Early Bird Bleed Monitoring System includes a Bleed Detection Array with integrated electrodes in a fully functional vascular access sheath. The Early Bird is designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury during endovascular procedures, such as a transcatheter aortic valve replacement (TAVR), hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to obtain vascular access. Visual and audible indicators on the Early Bird notify the clinician of the onset and progression of bleeding events.
About Saranas
Saranas is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company’s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs. For more information, please visit www.saranas.com.
Contacts
Zaffer Syed
Saranas, Inc.
713-357-1049
[email protected]
Saranas Recognized as One of Houston’s Most Innovative Companies
Houston, TX — Saranas Inc., a medical device company pioneering technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been named one of Houston’s most innovative companies. Saranas is the only medical device company to be honored at the inaugural Innovation Awards presentation sponsored by the Houston Business Journal on September 26, 2019.
Innovation honorees were selected by a panel of judges based upon their demonstrated success in innovation in the past 16 to 18 months. During this time, Saranas was granted de novo classification by the U.S. Food and Drug Administration (FDA) for their Early Bird®Bleed Monitoring System. Additionally, the company presented ‘first in human’ results at the Society for Cardiovascular Angiography Interventions (SCAI) Scientific Sessions, demonstrating that the Early Bird device is effective in early detection of internal bleeding.
One in five patients experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR) and percutaneous mechanical circulatory support. The Early Bird is the first and only device for real-time detection and monitoring of these types of complications.
“We are honored to be recognized as a leader in Houston’s rapidly expanding innovation ecosystem,” said Saranas President and CEO, Zaffer Syed. “We believe that the Early Bird is an important technology advancement that will significantly reduce bleeding complications and related healthcare costs, while improving clinical outcomes in patients undergoing endovascular procedures.”
About Saranas
Saranas is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company’s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs. For more information, please visit www.saranas.com.
Saranas Recognized as One of Houston’s Most Innovative Companies
Saranas Inc., a medical device company pioneering technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been named one of Houston’s most innovative companies.