Coronary Artery Disease (CAD)

Cardiovascular Systems, Inc. Announces First In-Human Experience With Company’s Propel™ Percutaneous Ventricular Assist Device

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Wednesday, March 16, 2022
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Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the first in-human experience with Propel, its first-generation percutaneous ventricular assist device (pVAD), offering hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (HR-PCI).

Key Points: 
  • Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the first in-human experience with Propel, its first-generation percutaneous ventricular assist device (pVAD), offering hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (HR-PCI).
  • Propel is percutaneously inserted, and the blood inlet portion of the device is positioned within the left ventricle below the aortic valve, and the outlet positioned above the aortic valve.
  • Propel was used at multiple support levels, with a hemodynamic power output and duration sufficient to maintain the stability of patients during their HR-PCI.
  • Conducting the first in-human cases outside the U.S. increases the confidence we have in Propel and furthers the development of this program.

Cardiovascular Systems, Inc. Reports Fiscal 2022 Second Quarter Financial Results

Retrieved on: 
Thursday, February 3, 2022
Health, Cardiology, Other Health, Medical Devices, Coronary Artery Disease (CAD), Peripheral Artery Disease (PAD), Cardiovascular Systems, Inc., OrbusNeich, CORONARY ARTERY DISEASE (CAD), PERIPHERAL ARTERY DISEASE (PAD), CARDIOVASCULAR SYSTEMS, INC., ORBUSNEICH

CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart.

Key Points: 
  • CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart.
  • According to the Centers for Disease Control and Prevention, 18 million people in the United States have CAD, the most common form of heart disease.
  • With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
  • See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events.

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

Retrieved on: 
Thursday, January 20, 2022
FDA, Health, Cardiology, Medical Devices, Scoreflex NC – Scoring PTCA Catheter Pivotal Clinical Study, Coronary Artery Disease (CAD), Cardiovascular Systems, Inc., OrbusNeich, SCOREFLEX NC – SCORING PTCA CATHETER PIVOTAL CLINICAL STUDY, CORONARY ARTERY DISEASE (CAD), CARDIOVASCULAR SYSTEMS, INC., ORBUSNEICH

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich Medical Company Ltd (OrbusNeich), announced FDA PMA approval of OrbusNeichs ScoreflexNC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (Scoreflex NC).

Key Points: 
  • Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich Medical Company Ltd (OrbusNeich), announced FDA PMA approval of OrbusNeichs ScoreflexNC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (Scoreflex NC).
  • Scoreflex NC is a focused force PTCA scoring balloon with a dual-wire system which creates a focal stress pattern to facilitate safe and controlled plaque modification at lower resolution pressure.
  • We are extremely pleased to receive FDA PMA approval for our Scoreflex NC device and are delighted to introduce this scoring balloon to U.S. physicians through our distribution partner, CSI, said David Chien, OrbusNeichs Chairman and CEO.
  • Two-hundred subjects were treated at 12 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure.

Cardiovascular Systems, Inc. Announces Development of Intravascular Lithotripsy Technology for the Treatment of Coronary and Peripheral Artery Diseases

Retrieved on: 
Thursday, January 13, 2022
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Lithotripsy has been used successfully for many years in the treatment of kidney and gall stones, and more recently has found application in treatment of calcified coronary and peripheral arteries.

Key Points: 
  • Lithotripsy has been used successfully for many years in the treatment of kidney and gall stones, and more recently has found application in treatment of calcified coronary and peripheral arteries.
  • The CSI IVL systems are designed to improve upon the limitations of incumbent technology, allowing physicians to cross and treat more challenging atherosclerotic lesions.
  • In coronary, CSIs current product offering, which is focused on the treatment of severely calcified coronary arteries using orbital atherectomy, targets 12% of percutaneous coronary interventions (PCI).
  • CSI is a registered trademark of Cardiovascular Systems, Inc. All other trademarks cited herein are owned by their respective owners.

Cardiovascular Systems, Inc. Reports Fiscal 2022 First Quarter Financial Results

Retrieved on: 
Tuesday, November 9, 2021
Health, Medical Devices, Surgery, Other Health, General Health, Cardiology, Biotechnology, Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD), Cardiovascular Systems, Inc., PERIPHERAL ARTERY DISEASE (PAD), CORONARY ARTERY DISEASE (CAD), CARDIOVASCULAR SYSTEMS, INC.

With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Key Points: 
  • With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
  • CAD is a life-threatening condition and a leading cause of death in men and women globally.
  • CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart.
  • The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow.

Cardiovascular Systems, Inc. Announces First In-Human Experience With Coronary Everolimus Drug Coated Balloon

Retrieved on: 
Thursday, November 4, 2021
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Everolimus, the active drug in CVTs DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.

Key Points: 
  • Everolimus, the active drug in CVTs DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.
  • Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease.
  • CVT was founded by Philippe Marco, MD, with the exclusive purpose to develop peripheral and coronary DCBs using everolimus.
  • CSI is a registered trademark of Cardiovascular Systems, Inc. All other trademarks cited herein are owned by their respective owners.

First Patients in Canada Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System

Retrieved on: 
Monday, August 30, 2021
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Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patients in Canada have been treated with its Diamondback 360Coronary Orbital Atherectomy System (OAS).

Key Points: 
  • Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patients in Canada have been treated with its Diamondback 360Coronary Orbital Atherectomy System (OAS).
  • Dr. Kalra said, Patients with calcific coronary artery disease can have poor clinical outcomes unless optimally treated.
  • Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, We are excited to announce the first commercial use of the Diamondback 360 Coronary OAS in Canada.
  • Indications: The Diamondback 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Cardiovascular Systems, Inc. Reports Fiscal 2021 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Wednesday, August 4, 2021
Health, Surgery, Cardiology, Medical Devices, Clinical medicine, Health, Medicine, Cardiovascular diseases, Amphetamine, Bariatrics, Body shape, Nutrition, Obesity, Diabetes, Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD), Cardiovascular Systems, Inc., PERIPHERAL ARTERY DISEASE (PAD), CORONARY ARTERY DISEASE (CAD), CARDIOVASCULAR SYSTEMS, INC.

With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Key Points: 
  • With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
  • Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.
  • CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart.
  • See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events.

New Study Demonstrates Exceptional Performance With Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy System (OAS) Dual Mode of Action

Retrieved on: 
Thursday, May 20, 2021
Biotechnology, Surgery, Medical devices, Health, Cardiology, Medicine, Clinical medicine, Medical specialties, Coronary catheterization, Angiography, Atherectomy, Coronary Artery Disease (CAD), Cardiovascular Systems, Inc., CORONARY ARTERY DISEASE (CAD), CARDIOVASCULAR SYSTEMS, INC.

Twenty consecutive patients with severely calcified lesions identified by coronary angiography were enrolled and treated by a single operator.

Key Points: 
  • Twenty consecutive patients with severely calcified lesions identified by coronary angiography were enrolled and treated by a single operator.
  • Stent delivery and subsequent stent expansion was subsequently achieved in all patients (100%).1\nSaid Avula, \xe2\x80\x9cOrbital atherectomy is used to facilitate stent expansion in severely calcified lesions.
  • In this small observational study we utilized OCT to demonstrate the dual mechanism of action of orbital atherectomy.
  • Observational Study Evaluating the Efficacy of Orbital Atherectomy in Treating Calcified Coronary Lesions.

Cardiovascular Systems, Inc. Reports Fiscal 2021 Third-Quarter Financial Results

Retrieved on: 
Thursday, May 6, 2021
Health, Surgery, Cardiology, Medical devices, Interventional radiology, Medical specialties, Medicine, Clinical medicine, Medical devices, Angioplasty, Stent, Artery, Peripheral Artery Disease (PAD), Coronary Artery Disease (CAD), Cardiovascular Systems, Inc., PERIPHERAL ARTERY DISEASE (PAD), CORONARY ARTERY DISEASE (CAD), CARDIOVASCULAR SYSTEMS, INC.

Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation.

Key Points: 
  • Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation.
  • These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue \xe2\x80\x94 a critical factor in preventing reoccurrences.
  • Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions.
  • CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart.