Post by icemandios on Dec 16, 2020 13:38:27 GMT
TransEnterix Announces Approval of Senhance® Surgical System in Russian Federation
Approval allows for marketing and sale of Senhance Surgical System for digital laparoscopy
TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Senhance ® Surgical System has received its registration certificate by Roszdravnadzor, the Russian medical device regulatory agency allowing for its sale and utilization throughout the Russian Federation.
“Russian regulatory approval is an important milestone for TransEnterix, and this is an underserved market for robotic surgery,” said Anthony Fernando, President and Chief Executive Officer of TransEnterix. “Russia has rapidly developed expertise and adoption of minimally invasive surgery over the past 10 years, but robotic surgery remains extremely limited in the region due to high per-procedure costs and the success of laparoscopic approaches. Senhance helps address these adoption hurdles. We have worked with BOWA previously to launch four Senhance programs in the Commonwealth of Independent States (CIS) region, and look forward to partnering to leverage this recent success in entering the largest CIS market.”
TransEnterix has been partnering with BOWA-electronic GmbH & Co. KG (BOWA), based in Germany, to commercialize the Senhance Surgical System in the CIS region over the past three years. BOWA, together with it’s wholly-owned subsidiary OOO “BOWA Eurasia”, have an established commercial and support presence in this region . They are well equipped to drive medical device sales and provide aftersale support to hospitals in the CIS region, including Russia, for the Senhance and BOWA’s own complementary surgical device portfolio of products.
The Senhance Surgical System is the first and only digital laparoscopic platform designed to maintain laparoscopic minimally invasive surgery standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including 3 mm microlaparoscopic instruments, eye-sensing camera control, and reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy. TransEnterix also recently launched the first machine vision system in robotic surgery in the US. This first-of-its-kind augmented intelligence capability is powered by the new Intelligent Surgical Unit™ on the Senhance Surgical System. Not all features are currently available in every market.
About TransEnterix
At TransEnterix, Inc., we are digitizing the interface between the surgeon and the patient to improve minimally invasive surgery (MIS) through a new category of care called Digital Laparoscopy. Digitizing the interface enables the use of advanced capabilities like augmented intelligence, connectivity and robotics in laparoscopy, and allows us to address the current clinical, cognitive and economic shortcomings in surgery. The system features the first machine vision system for use in robotic surgery which is powered by the new Intelligent Surgical Unit™ (ISU™) that enables augmented intelligence in surgery. The Senhance Surgical System brings the benefits of Digital Laparoscopy to patients around the world while staying true to the principles of value-based healthcare. Learn more about Digital Laparoscopy with the Senhance Surgical System here: Senhance.com/ . Now available for sale in the US, the EU, Japan, Russia, and select other countries. For a complete list of indications for use, please visit: www.transenterix.com/indications-for-use/ .
About BOWA Medical
BOWA develops and produces high-specification medical-technology solutions, and since 1977 has continuously developed into a leading technological supplier of energy-based surgical systems. With its three cutting-edge production sites in Gomaringen, Germany, Poznan, Poland, and Ashburton, UK, the core of the company is in the heart of Europe. International branches and sales offices in the Middle East, Russia, Brazil, Kazakhstan, Ukraine and additional countries across Asia guarantee global support for their customers. To find out more about, visit at www.bowa-medical.com .
Approval allows for marketing and sale of Senhance Surgical System for digital laparoscopy
TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Senhance ® Surgical System has received its registration certificate by Roszdravnadzor, the Russian medical device regulatory agency allowing for its sale and utilization throughout the Russian Federation.
“Russian regulatory approval is an important milestone for TransEnterix, and this is an underserved market for robotic surgery,” said Anthony Fernando, President and Chief Executive Officer of TransEnterix. “Russia has rapidly developed expertise and adoption of minimally invasive surgery over the past 10 years, but robotic surgery remains extremely limited in the region due to high per-procedure costs and the success of laparoscopic approaches. Senhance helps address these adoption hurdles. We have worked with BOWA previously to launch four Senhance programs in the Commonwealth of Independent States (CIS) region, and look forward to partnering to leverage this recent success in entering the largest CIS market.”
TransEnterix has been partnering with BOWA-electronic GmbH & Co. KG (BOWA), based in Germany, to commercialize the Senhance Surgical System in the CIS region over the past three years. BOWA, together with it’s wholly-owned subsidiary OOO “BOWA Eurasia”, have an established commercial and support presence in this region . They are well equipped to drive medical device sales and provide aftersale support to hospitals in the CIS region, including Russia, for the Senhance and BOWA’s own complementary surgical device portfolio of products.
The Senhance Surgical System is the first and only digital laparoscopic platform designed to maintain laparoscopic minimally invasive surgery standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including 3 mm microlaparoscopic instruments, eye-sensing camera control, and reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy. TransEnterix also recently launched the first machine vision system in robotic surgery in the US. This first-of-its-kind augmented intelligence capability is powered by the new Intelligent Surgical Unit™ on the Senhance Surgical System. Not all features are currently available in every market.
About TransEnterix
At TransEnterix, Inc., we are digitizing the interface between the surgeon and the patient to improve minimally invasive surgery (MIS) through a new category of care called Digital Laparoscopy. Digitizing the interface enables the use of advanced capabilities like augmented intelligence, connectivity and robotics in laparoscopy, and allows us to address the current clinical, cognitive and economic shortcomings in surgery. The system features the first machine vision system for use in robotic surgery which is powered by the new Intelligent Surgical Unit™ (ISU™) that enables augmented intelligence in surgery. The Senhance Surgical System brings the benefits of Digital Laparoscopy to patients around the world while staying true to the principles of value-based healthcare. Learn more about Digital Laparoscopy with the Senhance Surgical System here: Senhance.com/ . Now available for sale in the US, the EU, Japan, Russia, and select other countries. For a complete list of indications for use, please visit: www.transenterix.com/indications-for-use/ .
About BOWA Medical
BOWA develops and produces high-specification medical-technology solutions, and since 1977 has continuously developed into a leading technological supplier of energy-based surgical systems. With its three cutting-edge production sites in Gomaringen, Germany, Poznan, Poland, and Ashburton, UK, the core of the company is in the heart of Europe. International branches and sales offices in the Middle East, Russia, Brazil, Kazakhstan, Ukraine and additional countries across Asia guarantee global support for their customers. To find out more about, visit at www.bowa-medical.com .