Technology | October 27, 2016

FDA Clears Next Generation Interventional Cardiology Robotic System

Corindus CorPath GRX enhances procedural control and improves workflow, bringing added benefits to robotic-assisted coronary interventions

Corindus, Corpath, robotic navigation, Robotic PCI, CorPath GRX

October 27, 2016 — Corindus Vascular Robotics Inc. announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorPath GRX, the second generation of its vascular robotic system. Corindus expects to commence commercialization of CorPath GRX in the first quarter of 2017.

CorPath GRX significantly builds upon the original CorPath platform, adding a significant number of key upgrades that increase precision, improve workflow and extend the capabilities and range of procedures that can be performed robotically. These features include Active Guide Management, which enables control of the guide catheter along with robotic control of the guidewire and balloon or stent catheter, with 1 millimeter advancement, from the control console. This precise positioning will enable physicians to adjust guide catheter position during PCI procedures, and may expand use of CorPath to more complex cases. The new system also features a completely redesigned bedside unit, featuring an extended reach arm and a touchscreen display to streamline workflow.

"The new features of the next generation CorPath System, particularly the addition of active guide catheter management, will allow physicians to increase the complexity of procedures performed robotically,” said J. Aaron Grantham, M.D., chief medical officer of Corindus. “This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system."

Corindus' CorPath System is the only FDA-cleared medical device to bring robotic precision to percutaneous coronary interventions (PCI) and protects medical professionals from radiation exposure occurring in hospital cath labs.

“CorPath GRX is a critical advancement in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed,” said Mark Toland, president and CEO of Corindus. "GRX will enable us to build more robust and sustainable cardiovascular robotic programs with our hospital partners as we remain focused on providing the highest level of care to patients while protecting the health and wellness of the cath lab staff. We are excited to debut the GRX at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference later this week where we will be holding clinician demonstrations."

CorPath GRX will be on display for the first time at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference. Corindus will sponsor a breakfast symposium entitled "Robotic Therapy – Current Applications and Future Vision" on Monday, Oct. 31 at 7 a.m. Attendees can visit Corindus at Booth 1322 for an opportunity to use CorPath GRX with an advanced simulator.

For more information: www.corindus.com

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init