f Uncategorized | Standard Bariatrics

Standard Bariatrics

In The News

Category Archives: Uncategorized

Standard Bariatrics® Titan SGS Stapling Technology for Sleeve Gastrectomy Receives FDA Clearance

By | Uncategorized | No Comments

Titan SGS with Standard Power Unit

Cincinnati, Ohio – May 4, 2021 – Standard Bariatrics® announced today that its novel Titan SGS™ stapling technology, designed specifically for bariatric sleeve surgery, has been cleared by the US Food and Drug Administration (FDA).1 The Titan SGS™ first-of-its-kind design offers surgeons performing sleeve gastrectomy procedures the industry’s longest continuous staple cutline of 23 centimeters.2

“This clearance marks another important milestone in our mission to create solutions that can lead to more consistent and repeatable bariatric surgery outcomes,” said Jonathan Thompson, MD, Founder and Chief Medical Officer of Standard Bariatrics®. “The Titan SGS™ stapling technology is the natural evolution of the Standard Clamp™ anatomy-based approach to sleeve gastrectomy, which has been successfully used in more than 10,000 procedures.”

With a purposeful design, driven by the needs of today’s bariatric surgeon performing sleeve gastrectomy, Titan SGS™ provides real-time audio and visual feedback, graduated staple height formation, tissue-sensing technology and a firing cycle optimized particularly for the patient’s gastric tissue during gastrectomy pouch creation.1,3,4 While every patient’s anatomy is different, the Titan SGS™ long staple line enables surgeons to plan and place staples in one firing, minimizing variations often associated with the current use of multiple overlapping short-cartridge staple firings.5

The design ensures more consistent staple formation across the entire 23-centimeter cutline for improved staple-line strength and fewer malformed staples than competitive staplers that offer short cartridges for more general surgical use.2,3,4 The Titan SGS™ design may result in a more secure staple line and fewer chances of leaks, as evidenced with higher burst pressures.3 Because Titan SGS™ takes approximately half the time to create the staple line,6,7 it can also potentially improve procedure time and operational efficiencies.2,7

Titan SGS

Titan SGS™ was cleared after a successful 62-patient multi-center trial in longitudinal gastric stapling.2 The University of Buffalo Department of Surgery in the Jacobs School of Medicine and Biomedical Sciences (UBMD) was the first to use Titan SGS™. Steven Schwaitzberg, MD, professor and chair of surgery in the Jacobs School and president of UBMD Surgery said, “Gastric sleeve is the predominant bariatric procedure in the world today and this key refinement will serve patients well for years to come.”

“We are focused on bringing innovation and breakthroughs in science and surgery to our users,” said Matt Sokany, Chief Executive Officer of Standard Bariatrics®. “We believe Titan SGS™ has the potential to overcome the challenges bariatric surgeons may encounter with the use of existing short-cartridge stapling technology.”

Surgeons interested in learning more about Titan SGS™ stapling technology or about applying for training and use can contact Ronald Galovich, Chief Commercial Officer of Standard Bariatrics®, at 513.620.7751 or ron@standardbariatrics.com.

About Standard Bariatrics®, Inc.
Standard Bariatrics, Inc., is a Cincinnati-based surgical procedure company focused on the innovative development and commercialization of medical devices. Driven by a passionate group of surgical innovators, the company continues to release surgical solutions designed to address significant market opportunities. A seasoned team of medical and management professionals, Standard Bariatrics® has more than 175 combined years of experience in developing and commercializing novel medical device technologies with a record of achieving both clinical and economic excellence for patients and providers.

Standard Bariatrics® is supported through early investment from Queen City Angels and CincyTech, and more recently Series A lead investors RiverVest®, Hatteras Venture Partners and Emergent Medical Partners.
For more information, visit http://www.standardbariatrics.com or call 513-620-7751.

1. Indications for Use, K210278: “The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation.”
2. Goodman, Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection.2020
3. Slayer, Spuzzillo, Wakefield, et al. Assessment of a novel stapler performance for laparoscopic sleeve gastrectomy.2020
4. Yeo, Thompson, Hanseman, Diwan, Dunki-Jacobs, et al. Increased staple loading pressures and reduced staple heights in laparoscopic sleeve gastrectomy reduce intraoperative bleeding.2020
5. Toro, Lin, Patel, et al. Association of Radiographic Morphology with Early Gastroesophageal Reflux Disease and Satiety Control after Sleeve Gastrectomy.2014
6. Titan Pre-clinical 510K data on file
7. Varban, Niemann, Stricklen, et al. Far from Standardized. Journal of Laparoendoscopic & Advanced Surgical techniques.2107

Media Contact
Ronald Galovich
Chief Commercial Officer, Standard Bariatrics®

Standard Bariatrics Names Kurt Azarbarzin as Chairman of the Board of Directors

By | Uncategorized | No Comments

Azarbarzin brings vast experience in medical devices, surgical stapling, innovation, and successful execution of growth strategies

Blue Ash, OH – January 30, 2019 – Standard Bariatrics, Inc. today announced the appointment of Kurt Azarbarzin as Chairman of the Board of Directors, effective immediately.

Azarbarzin, currently serving as Chief Technology Officer at CONMED Corporation (“CONMED”), brings 35 years of experience in the medical device industry. Prior to joining CONMED, he was Founder and CEO of SurgiQuest, Inc. (“SurgiQuest”), a privately-held venture-backed company that developed, manufactured, and marketed innovative access technologies for minimally invasive surgery. While at SurgiQuest, he commercialized, financed, and led a growth strategy that created significant shareholder value and resulted in a successful acquisition of the company by CONMED for $265 million in November 2015. Prior to SurgiQuest, Azarbarzin spent 21 years at United States Surgical Corporation/Tyco, most recently as Global Vice President of Research and Development.

Read More

Standard Bariatrics Receives FDA Indication for #1 Bariatric Surgical Procedure

By | Uncategorized | No Comments

Innovative laparoscopic bariatric device manufacturer announces FDA 510(k) clearance for Sleeve Gastrectomy

Cincinnati, Ohio – October 22, 2018 – Standard Bariatrics, an innovator of surgical devices, has received a sleeve gastrectomy indication from the Food and Drug Administration (FDA) for the STANDARD CLAMP®.1

“Standard Bariatrics is committed to creating superior bariatric surgery outcomes through device innovations. The acceptance of the supplemental data by the FDA to expand the U.S. indications of the STANDARD CLAMP® is another significant milestone for the Company,” said Jonathan Thompson MD, Founder and Chief Medical Officer of Standard Bariatrics. “With the patient’s health top priority, we aimed to standardize an anatomy-based approach to sleeve gastrectomy.” Read More