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

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Overlay Init