Cath Lab

The catheterization lab channel includes content related to interventional technologies for coronary and peripheral artery disease (PAD). Other cath lab transcatheter device technologies covered on this page included percutaneous treatment for stroke, venous interventions, heart valves, hypertension, heart failure and percutenous coronary interventions (PCI).

ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab
FDA Clears SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System

July 13, 2021 — East End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company ...

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The Robocath R-One cath lab robotic platform being used in Rouen, France, to guide a cardiac Cath procedure. The system gained European approval in 2019. Robocath is now partnering with Philips France and Rennes University Hospital to develop the robotic system to treat strokes.
News | Stroke
Robocath, Philips and Rennes University Hospital Codevelop Robotic Stroke Intervention System

July 7, 2021 – Robocath, a company that designs, develops and commercializes cath lab robotic solutions to treat ...

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The FDA has cleared Angel Medical Systems' second-generation AngelMed Guardian device. The implantable cardiac device detects and warns patients if they are having an acute coronary syndrome (ACS) event, including silent heart attacks. The new, second-generation device is enhanced with ease-of-use adaptations and an updated, long life battery that could potentially double the life of the implanted device
News | Cardiac Diagnostics
FDA Approves AngelMed Enhanced Real-Time Cardiac Monitor for Acute Coronary Syndrome (ACS) Events

July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc. second-generation ...

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Abbott says the Xience fluoropolymer coating interacts with blood proteins in a manner that reduces thrombus formation. This feature makes the stent safer to use for shorter duration DAPT.
News | Stents
FDA Clears Xience Stent for One Month DAPT in High Risk Bleeding Patients

June 30, 2021 — Abbott announced its Xience family of drug-eluting coronary stents received U.S. Food and Drug ...

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The balloon inflation to deploy an Edwards Lifesciences Sapien 3 TAVR valve in a failed surgical tricuspid valve. This valve-in-valve (VIV) procedures was performed at Beaumont in a 34-year-old female patient who was determined to be too high of a surgical risk for SAVR.
News | Structural Heart
Beaumont Performs Rare Tricuspid Transcatheter Valve-in-valve Procedure

June 29, 2021 – Cardiologists at Beaumont Health successfully replaced a 34-year-old woman’s tricuspid valve in a rare ...

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ScImage went live in March at Peak Surgery Center of Avondale, Arizona, and was developed in cooperation with the providers from multispecialty cardiovascular group Peak Heart & Vascular, which has locations in Avondale, Surprise, Ariz., and Flagstaff, Ariz. ScImage’s PICOM365 Cloud provides image review, storage and advanced structured reporting to manage the complex, measurement-centric cardiac catheterization procedures performed in the facilities.
News | Cardiovascular Information Systems (CVIS)
Outpatient Cath Lab Adopts PICOM365 Cloud With Hemodynamics 

June 29, 2021 - ScImage Inc.has partnered with National Cardiovascular Management (NCM), a national consulting and ...

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CentraCare completed the first structural heart procedure in the world guided by a new 4-D hologram technology developed by EchoPixel. The augmented reality technology aims to reduce reduce procedure time, improve accuracy of the procedure, and reduce risk of complications.
Feature | Virtual and Augmented Reality
First 4D Hologram Guided Structural Heart Procedure Performed for LAA Occlusion

June 28, 2021 — CentraCare, one of the largest health systems in Minnesota, successfully completed the first structural ...

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Clinical trial quality data can be derived from national cardiovascular registries, which may change how trials are performed in the future.
News | Cardiovascular Clinical Studies
Study Shows ACC Registry Data Could Support Cardiac Clinical Trials

June 24, 2021 — Data captured in American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) regis ...

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The Philips Healthcare SyncVision system co-registers iFR hemodynamic blood flow measurements to live angiograms to enable easier assessment of which lesions in a vessel need to be stented and which can be left alone and treated medically.
News | FFR Technologies
First Patient Enrolled in DEFINE GPS Study to Assess PCI Guided by Co-registered iFR Versus Angiography

June 22, 2021 – Philips Healthcare announced the official start of the DEFINE GPS study, with the first patient being ...

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Boston Scientific Makes a Comeback With Positive Clinical Data With its Second Iteration Acurate neo2 TAVR Valve
Blog | Structural Heart
Boston Scientific Makes a Comeback With Positive Clinical Data for its Second Iteration Acurate neo2 TAVR Valve

It is brutal and very expensive to bring a new transcatheter valve to market. Boston Scientific invested vast amounts of ...

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Some of the top technology news from ACC 2021. Top left, the LAAOS III trial showed benefit when surgeons seal off the LAA during other open heart procedures. Bottom left, the ReCor Paradise renal denervation system helped lower blood pressure in patients who did not respond to medication. Top right, for patients with both heart failure and AFib it makes no differences is therapy is focused on controlling the heart rhythm or heart rate. Bottom right, the FLOWER-MI trial found no benefit to FFR-guided PCI.
Feature | ACC | By Dave Fornell, Editor
Key Cardiology Technology Takeaways at ACC 2021

Here are the top 10 takeaways from the late-breaking studies on cardiovascular technologies presented at the 2021 Americ ...

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Two years ago a study raised concerns that paclitaxel-coated devices may cause increased mortality in peripheral artery disease patients. However, numerous studies now show there is no risk of increased mortality. The most recent study is the SAFE-PAD study presented at ACC.21.
News | Peripheral Artery Disease (PAD)
SAFE-PAD Study Shows No Safety Issues With Paclitaxel-coated Devices In Peripheral Artery Disease

June 7, 2021 — A couple years ago a study showed a mortality safety signal in patients who underwent peripheral artery ...

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The 30-day outcomes from the TRISCEND study of the transfemoral Evoque tricuspid valve replacement system demonstrated technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) and symptoms in patients with clinically significant TR.
News | Structural Heart
Edwards LifeSciences Reports Positive Clinical Updates on its Transcatheter Mitral and Tricuspid Valves

June 7, 2021 — Edwards Lifesciences recently announced that clinical results from the company's transcatheter mitral and ...

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The Aortix intra-aortic axial flow pump offers hemodynamic support to relieve some of the heart’s workload, allowing the heart to recover while more effectively pushing blood flow to the kidneys.
News | Heart Failure
Cardiologists at Henry Ford Are First in U.S. to Implant Aortix Heart Pump to Treat Heart Failure

June 7, 2021 – Cardiologists at Henry Ford Hospital are first in the U.S. and second in the world to implant a ...

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The HLT, Bracco, Meridian II TAVR Valve System.
Feature | Structural Heart | Dave Fornell, Editor
Bracco Moving Forward With HLT Meridian TAVR Valve

June 2, 2021 — The startup company HLT is a part of the Bracco Group, which is developing a new transcatheter aortic ...

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