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Congenital Heart Disease
ACC: New Study Identifies Link Between Congenital Heart Disease Prevalence and High-Altitude Environments
09/18/2024
The global prevalence of congenital heart disease is higher among women who live in high altitudes, according to a new study being presented at ACC Latin America 2024 in Punta Cana, Dominican Republic.
The global prevalence of congenital heart disease is higher among women who live in high altitudes, according to a new study being presented at ACC Latin America 2024 in Punta Cana, Dominican Republic.
The global prevalence of...
09/18/2024
Cath Lab Digest
Carotid Stenting
InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard Prime Carotid Stent System
09/18/2024
The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May.
The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May.
The PMA application is based on...
09/18/2024
Cath Lab Digest
Prevention
Yale Study: Jails Should Be a Focus of Cardiovascular Disease Prevention
09/18/2024
Individuals released from jail are more likely to have uncontrolled cardiovascular disease (CVD) risk factors than those released from prison, a new Yale-led study finds.
Individuals released from jail are more likely to have uncontrolled cardiovascular disease (CVD) risk factors than those released from prison, a new Yale-led study finds.
Individuals released from jail...
09/18/2024
Cath Lab Digest

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Carotid Artery Revascularization
Boston Scientific Closes Acquisition of Silk Road Medical, Inc.
09/17/2024
Silk Road Medical, Inc., is a medical device company that pioneered a new approach for stroke prevention and the treatment of carotid artery disease through a minimally invasive procedure called transcarotid artery revascularization (TCAR).
Silk Road Medical, Inc., is a medical device company that pioneered a new approach for stroke prevention and the treatment of carotid artery disease through a minimally invasive procedure called transcarotid artery revascularization (TCAR).
Silk Road Medical, Inc., is a...
09/17/2024
Cath Lab Digest
Professional Training
Calling Clinicians: Dartmouth Health Announces Launch of Medical Device Innovations Training Program
09/17/2024
"The medical device ecosystem needs active clinicians to guide the development process at companies and regulatory agencies," says Aaron V. Kaplan, MD, FACC, FNAI. “This program will provide scholars with a deep understanding of the medical...
"The medical device ecosystem needs active clinicians to guide the development process at companies and regulatory agencies," says Aaron V. Kaplan, MD, FACC, FNAI. “This program will provide scholars with a deep understanding of the medical...
"The medical device ecosystem...
09/17/2024
Cath Lab Digest
Intravascular Imaging
SpectraWAVE Announces $50M Series B Financing to Drive Commercial Expansion and Product Additions to the HyperVue Imaging System
09/17/2024
HyperVue is the first intravascular imaging technology to combine two important imaging technologies, DeepOCT and NIRS, while optimizing for image quality and procedural efficiency in the cath lab, including no-flush catheter prep, fast and...
HyperVue is the first intravascular imaging technology to combine two important imaging technologies, DeepOCT and NIRS, while optimizing for image quality and procedural efficiency in the cath lab, including no-flush catheter prep, fast and...
HyperVue is the first...
09/17/2024
Cath Lab Digest

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Pediatric Stenting
FDA Approves First-of-Its-Kind Cardiac Stent for Babies
09/17/2024
Based on data from a national clinical trial led by Children’s Hospital Los Angeles, the FDA approved the Minima stent for neonates, infants, and young children with aortic coarctation or branch pulmonary artery stenosis.
Based on data from a national clinical trial led by Children’s Hospital Los Angeles, the FDA approved the Minima stent for neonates, infants, and young children with aortic coarctation or branch pulmonary artery stenosis.
Based on data from a national...
09/17/2024
Cath Lab Digest
Philips LumiGuide Navigation Wire
Intravascular Imaging
Philips Announces FDA Approval for Enhanced LumiGuide Guidewire and Marks 1000th Patient Treated With Its Breakthrough 3D Device Guidance Technology
09/17/2024
“LumiGuide unlocks the color visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically...
“LumiGuide unlocks the color visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically...
“LumiGuide unlocks the color...
09/17/2024
Cath Lab Digest
Shockwave E8 Peripheral IVL Catheter
Intravascular Lithotripsy
Shockwave Medical Expands U.S. Peripheral IVL Portfolio with Enhanced Catheter
09/16/2024
The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).  
The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).  
The Shockwave E8 catheter is...
09/16/2024
Cath Lab Digest

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Optical Coherence Tomography (OCT)
OCCUPI Trial: OCT Outperforms Conventional Angiography for Stent Guidance in Complex Cases
09/12/2024
“Our results show that the use of OCT guidance improves clinical outcomes and enhances safety and effectiveness of coronary stenting, reducing cardiac death, MI, stent thrombosis, and the need for revascularisation by 38% in a group of very...
“Our results show that the use of OCT guidance improves clinical outcomes and enhances safety and effectiveness of coronary stenting, reducing cardiac death, MI, stent thrombosis, and the need for revascularisation by 38% in a group of very...
“Our results show that the use...
09/12/2024
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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