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Previous research has found that AI can determine demographic features from medical images.
AI and Imaging
Implementing Medical Imaging AI: Issues to Consider
10/04/2024
As of August 7, 2024, the U.S. FDA has authorized 950 AI/ML-enabled medical devices; more than 100 of these were authorized this year. The rate of algorithm authorization is surging at an exponential pace. 
As of August 7, 2024, the U.S. FDA has authorized 950 AI/ML-enabled medical devices; more than 100 of these were authorized this year. The rate of algorithm authorization is surging at an exponential pace. 
As of August 7, 2024, the U.S....
10/04/2024
Cath Lab Digest
Risk Markers
New Cardiovascular Disease Risk Marker Discovered in Older Women
10/03/2024
“We can show that a low level of the natural antibody to phosphorylcholine can be used as a risk marker for cardiovascular disease also in women, independent of previously known risk factors," said Dr. Johan Frostegård.
“We can show that a low level of the natural antibody to phosphorylcholine can be used as a risk marker for cardiovascular disease also in women, independent of previously known risk factors," said Dr. Johan Frostegård.
“We can show that a low level of...
10/03/2024
Cath Lab Digest

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thrombectomy
Surmodics Receives FDA 510(k) Clearance for Pounce™ XL Thrombectomy System, Expanding the Pounce Thrombectomy Platform to Larger Peripheral Arteries up to 10 mm in Diameter
10/02/2024
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter, making it suitable for iliac, femoral, and other arteries within...
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter, making it suitable for iliac, femoral, and other arteries within...
The Pounce XL Thrombectomy...
10/02/2024
Vascular Disease Management
Heart Failure
Global Study Highlights the Life-Saving Impact of Guideline-Directed Medical Therapy (GDMT) in Heart Failure Patients
10/02/2024
“There are significant regional disparities that exist across the world, and this study draws attention to the fact that heart failure is not a monolithic entity, but a condition that varies greatly based on socioeconomic and cultural...
“There are significant regional disparities that exist across the world, and this study draws attention to the fact that heart failure is not a monolithic entity, but a condition that varies greatly based on socioeconomic and cultural...
“There are significant regional...
10/02/2024
Cath Lab Digest
Elucid PlaqueIQ
Image Analysis Software
Elucid Receives U.S. 510(k) Clearance of PlaqueIQ Image Analysis Software to Aid Cardiovascular Disease Assessment
10/01/2024
PlaqueIQ is the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques.
PlaqueIQ is the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques.
PlaqueIQ is the first...
10/01/2024
Cath Lab Digest

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ASD Closure
Gore Releases 3-Year Data For The Gore Cardioform ASD Occluder
10/01/2024
"The GORE CARDIOFORM ASD Occluder continues to be a useful device for interventional cardiologists,” said Robert J. Sommer, MD, co-principal investigator of the ASSURED Study.
"The GORE CARDIOFORM ASD Occluder continues to be a useful device for interventional cardiologists,” said Robert J. Sommer, MD, co-principal investigator of the ASSURED Study.
"The GORE CARDIOFORM ASD...
10/01/2024
Cath Lab Digest
Figure: The images show a large atherosclerotic plaque in a carotid artery. The top panels show an axial view (left) and a longitudinal view (right). The 3D volumetric representation (bottom) provides a detailed and accurate visualization of the plaque, allowing a thorough assessment of the disease.
Atherosclerosis
Presence of Subclinical Atherosclerosis Is Marker of Mortality and Its Progression Increases Risk of Death
09/30/2024
“The long asymptomatic phase of the disease presents a window of opportunity that has not been exploited in the younger population,” says lead author Valentin Fuster, MD, PhD.
“The long asymptomatic phase of the disease presents a window of opportunity that has not been exploited in the younger population,” says lead author Valentin Fuster, MD, PhD.
“The long asymptomatic phase of...
09/30/2024
Cath Lab Digest
ULC PCI
Intravascular Imaging
IVUS and iFR Technologies Receive Top-Level Recognition in New ESC Guidelines, Reinforcing Their Role in Optimizing Coronary Interventions and Patient Outcomes
09/30/2024
Intravascular ultrasound (IVUS) and instantaneous wave-free ratio (iFR) have both demonstrated significant benefits in improving patient outcomes through numerous large-scale randomized trials like DEFINE FLAIR and iFR SWEDEHEART.
Intravascular ultrasound (IVUS) and instantaneous wave-free ratio (iFR) have both demonstrated significant benefits in improving patient outcomes through numerous large-scale randomized trials like DEFINE FLAIR and iFR SWEDEHEART.
Intravascular ultrasound (IVUS)...
09/30/2024
Cath Lab Digest

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heart failure
One-Year Data Show Excellent Outcomes for Endotronix Cordella Pulmonary Artery Sensor System
09/30/2024
"These data are consistent and compelling validating that PA pressure-guided therapy improves heart failure outcomes," said Liviu Klein, MD.
"These data are consistent and compelling validating that PA pressure-guided therapy improves heart failure outcomes," said Liviu Klein, MD.
"These data are consistent and...
09/30/2024
Cath Lab Digest
Heart Failure
Alnylam Highlights New Data From HELIOS-B Study of Vutrisiran for the Treatment of Transthyretin Amyloidosis With Cardiomyopathy
09/30/2024
“These new data show that vutrisiran attenuated measures of disease progression across multiple domains of cardiac structure and function, NT-proBNP and troponin I, in a contemporary ATTR-CM patient population,” said Pushkal Garg, MD.
“These new data show that vutrisiran attenuated measures of disease progression across multiple domains of cardiac structure and function, NT-proBNP and troponin I, in a contemporary ATTR-CM patient population,” said Pushkal Garg, MD.
“These new data show that...
09/30/2024
Cath Lab Digest

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Bioadaptors
TCT: DynamX Bioadaptor Demonstrates Significant Improvement Over Contemporary Drug-Eluting Stent in Patients with Acute Coronary Syndrome and Complex Lesion Subsets After Six Months
10/29/2024
Data demonstrate significant benefit of the DynamX® Coronary Bioadaptor System compared to a contemporary zotarolimus drug-eluting stent for target lesion failure in complex patient population subsets from the INFINITY-SWEDEHEART RCT.
Data demonstrate significant benefit of the DynamX® Coronary Bioadaptor System compared to a contemporary zotarolimus drug-eluting stent for target lesion failure in complex patient population subsets from the INFINITY-SWEDEHEART RCT.
Data demonstrate significant...
10/29/2024
Cath Lab Digest
Aortic Stenosis
TCT: Real-World Evidence Demonstrates Improved Survival in Asymptomatic Aortic Stenosis Patients Undergoing Aortic Valve Replacement (AVR)
10/29/2024
The study analyzed data from over 2 million patients in a real-world database of 29 teaching and non-teaching U.S. health systems.
The study analyzed data from over 2 million patients in a real-world database of 29 teaching and non-teaching U.S. health systems.
The study analyzed data from...
10/29/2024
Cath Lab Digest
Zilver Vena Stent
Zilver Vena Stent Shows High Patency Across All Patient Groups in Three-Year Clinical Study
10/29/2024
Bloomington, Ind. — Cook Medical’s Zilver Vena® Venous Self-Expanding Stent has shown high rates of patency sustained for three years, according to recently published data in the Journal of Vascular and Interventional Radiology (JVIR).1 The...
Bloomington, Ind. — Cook Medical’s Zilver Vena® Venous Self-Expanding Stent has shown high rates of patency sustained for three years, according to recently published data in the Journal of Vascular and Interventional Radiology (JVIR).1 The...
Bloomington, Ind. — Cook...
10/29/2024
Vascular Disease Management
Coronary Atherectomy
TCT: Treating Severe Calcification With an Atherectomy Device Does Not Improve Cardiac Stenting Outcomes, ECLIPSE Study Finds
10/29/2024
"The use of orbital atherectomy may be reserved for the most extreme cases for which the operator does not believe that balloon angioplasty would be likely to safely cross or pre-dilate the calcified lesion,” said Gregg Stone, MD.
"The use of orbital atherectomy may be reserved for the most extreme cases for which the operator does not believe that balloon angioplasty would be likely to safely cross or pre-dilate the calcified lesion,” said Gregg Stone, MD.
"The use of orbital atherectomy...
10/29/2024
Cath Lab Digest
Large Bore Closure
TCT: Vivasure Announces Positive Results of PATCH IDE Pivotal Study Indicating Safety and Efficacy of PerQseal Large Hole Closure Device
10/29/2024
The Vivasure PerQseal® Closure Device System (PerQSeal) is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices.
The Vivasure PerQseal® Closure Device System (PerQSeal) is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices.
The Vivasure PerQseal® Closure...
10/29/2024
Cath Lab Digest
Renal denervation
TCT: SPYRAL HTN-ON MED Study Shows Significant, Consistent, Long-Term Blood Pressure Lowering Effect at Two Years
10/29/2024
"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari.
"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari.
"These findings are a key step...
10/29/2024
Cath Lab Digest
EMPOWER CAD Completed Enrollment
Intravascular Lithotripsy
TCT: Shockwave Medical Completes Enrollment in All-Female Coronary IVL Study
10/28/2024
EMPOWER CAD is seeking to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and...
EMPOWER CAD is seeking to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and...
EMPOWER CAD is seeking to...
10/28/2024
Cath Lab Digest
aortic valve stenosis
TCT: Cardiawave Announces Positive Six-Month Data From Valvosoft Pivotal Study
10/28/2024
High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue. The treatment is designed to be repeatable over time, as needed, to manage disease progression.
High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue. The treatment is designed to be repeatable over time, as needed, to manage disease progression.
High-intensity focused...
10/28/2024
Cath Lab Digest
Pulmonary Embolism
TCT: RESCUE II Trial Demonstrates the Feasibility of On-The-Table Pharmacomechanical Lysis Without Post-Procedure Infusion in Treating Acute Pulmonary Embolism
10/28/2024
The BASHIR™ Endovascular Catheter was used to deliver 4mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (PA). The study showed that the independent core laboratory assessed primary endpoint of the right...
The BASHIR™ Endovascular Catheter was used to deliver 4mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (PA). The study showed that the independent core laboratory assessed primary endpoint of the right...
The BASHIR™ Endovascular...
10/28/2024
Cath Lab Digest
EARLY TAVR
TCT: Groundbreaking Data Demonstrate Superiority of EARLY TAVR in Asymptomatic Severe Aortic Stenosis Patients
10/28/2024
With a median follow up of 3.8 years, the data demonstrated superiority of early TAVR, with 26.8% of the 455 patients in the TAVR arm experiencing death, stroke or unplanned cardiovascular hospitalization compared to 45.3% of the 446 patients...
With a median follow up of 3.8 years, the data demonstrated superiority of early TAVR, with 26.8% of the 455 patients in the TAVR arm experiencing death, stroke or unplanned cardiovascular hospitalization compared to 45.3% of the 446 patients...
With a median follow up of 3.8...
10/28/2024
Cath Lab Digest

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Bioadaptors
TCT: DynamX Bioadaptor Demonstrates Significant Improvement Over Contemporary Drug-Eluting Stent in Patients with Acute Coronary Syndrome and Complex Lesion Subsets After Six Months
10/29/2024
Data demonstrate significant benefit of the DynamX® Coronary Bioadaptor System compared to a contemporary zotarolimus drug-eluting stent for target lesion failure in complex patient population subsets from the INFINITY-SWEDEHEART RCT.
Data demonstrate significant benefit of the DynamX® Coronary Bioadaptor System compared to a contemporary zotarolimus drug-eluting stent for target lesion failure in complex patient population subsets from the INFINITY-SWEDEHEART RCT.
Data demonstrate significant...
10/29/2024
Cath Lab Digest
Aortic Stenosis
TCT: Real-World Evidence Demonstrates Improved Survival in Asymptomatic Aortic Stenosis Patients Undergoing Aortic Valve Replacement (AVR)
10/29/2024
The study analyzed data from over 2 million patients in a real-world database of 29 teaching and non-teaching U.S. health systems.
The study analyzed data from over 2 million patients in a real-world database of 29 teaching and non-teaching U.S. health systems.
The study analyzed data from...
10/29/2024
Cath Lab Digest
Zilver Vena Stent
Zilver Vena Stent Shows High Patency Across All Patient Groups in Three-Year Clinical Study
10/29/2024
Bloomington, Ind. — Cook Medical’s Zilver Vena® Venous Self-Expanding Stent has shown high rates of patency sustained for three years, according to recently published data in the Journal of Vascular and Interventional Radiology (JVIR).1 The...
Bloomington, Ind. — Cook Medical’s Zilver Vena® Venous Self-Expanding Stent has shown high rates of patency sustained for three years, according to recently published data in the Journal of Vascular and Interventional Radiology (JVIR).1 The...
Bloomington, Ind. — Cook...
10/29/2024
Vascular Disease Management
Coronary Atherectomy
TCT: Treating Severe Calcification With an Atherectomy Device Does Not Improve Cardiac Stenting Outcomes, ECLIPSE Study Finds
10/29/2024
"The use of orbital atherectomy may be reserved for the most extreme cases for which the operator does not believe that balloon angioplasty would be likely to safely cross or pre-dilate the calcified lesion,” said Gregg Stone, MD.
"The use of orbital atherectomy may be reserved for the most extreme cases for which the operator does not believe that balloon angioplasty would be likely to safely cross or pre-dilate the calcified lesion,” said Gregg Stone, MD.
"The use of orbital atherectomy...
10/29/2024
Cath Lab Digest
Large Bore Closure
TCT: Vivasure Announces Positive Results of PATCH IDE Pivotal Study Indicating Safety and Efficacy of PerQseal Large Hole Closure Device
10/29/2024
The Vivasure PerQseal® Closure Device System (PerQSeal) is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices.
The Vivasure PerQseal® Closure Device System (PerQSeal) is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices.
The Vivasure PerQseal® Closure...
10/29/2024
Cath Lab Digest
Clinical Images
Coronary Stent and Balloon Entrapment Following Delivery Device Perforation
10/29/2024
The authors present the first reported case of stent and balloon entrapment treated by placing a new stent using the crush technique with intra-coronary optical coherence tomography.
The authors present the first reported case of stent and balloon entrapment treated by placing a new stent using the crush technique with intra-coronary optical coherence tomography.
The authors present the first...
10/29/2024
Journal of Invasive Cardiology
Renal denervation
TCT: SPYRAL HTN-ON MED Study Shows Significant, Consistent, Long-Term Blood Pressure Lowering Effect at Two Years
10/29/2024
"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari.
"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari.
"These findings are a key step...
10/29/2024
Cath Lab Digest
EMPOWER CAD Completed Enrollment
Intravascular Lithotripsy
TCT: Shockwave Medical Completes Enrollment in All-Female Coronary IVL Study
10/28/2024
EMPOWER CAD is seeking to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and...
EMPOWER CAD is seeking to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and...
EMPOWER CAD is seeking to...
10/28/2024
Cath Lab Digest
aortic valve stenosis
TCT: Cardiawave Announces Positive Six-Month Data From Valvosoft Pivotal Study
10/28/2024
High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue. The treatment is designed to be repeatable over time, as needed, to manage disease progression.
High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue. The treatment is designed to be repeatable over time, as needed, to manage disease progression.
High-intensity focused...
10/28/2024
Cath Lab Digest
Pulmonary Embolism
TCT: RESCUE II Trial Demonstrates the Feasibility of On-The-Table Pharmacomechanical Lysis Without Post-Procedure Infusion in Treating Acute Pulmonary Embolism
10/28/2024
The BASHIR™ Endovascular Catheter was used to deliver 4mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (PA). The study showed that the independent core laboratory assessed primary endpoint of the right...
The BASHIR™ Endovascular Catheter was used to deliver 4mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (PA). The study showed that the independent core laboratory assessed primary endpoint of the right...
The BASHIR™ Endovascular...
10/28/2024
Cath Lab Digest

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