Coronary

Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis

Retrieved on: 
Wednesday, March 27, 2024
Hemodynamics, Aortic stenosis, Patient, Medtronic, Quality of life, Heart failure, Coronary, TAVR, FX, FDA, Physician

DUBLIN, March 27, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.

Key Points: 
  • DUBLIN, March 27, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.
  • The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.
  • The Evolut FX+ TAVR system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of the Evolut TAVR system.
  • If left untreated, 50% of patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.2
    The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the U.S.

Cleerly® Announces CERTAIN Multicenter Clinical Trial Results

Retrieved on: 
Thursday, February 8, 2024
Health, Clinical Trials, Cardiology, Other Health, Drug, Ischemia, MD, American College, Derivation, Cole, Detection, Medicine, Intelligence, Artificial intelligence, Coronary ischemia, Science, Atherosclerosis, Society, CCTA, Myocardial perfusion imaging, PMID, Plaque, SPECT, PET, FDA, Adenosine, American Journal of Roentgenology, Diagnosis, Patient, Stenosis, Moyamoya disease, Validation, Splenic infarction, Physician, Health literacy, Journal, Coronary artery disease, Coronary, Medical imaging

These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.

Key Points: 
  • These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.
  • In all multicenter and single clinical studies performed to date, Cleerly’s products have consistently demonstrated robust clinical utility, including higher diagnostic accuracy and stronger prognostic risk stratification over such historical tests as nuclear SPECT stress testing and FFRCT2-7.
  • Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials.
  • Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway.

Medtronic announces FDA approval of minimally invasive device to treat hypertension

Retrieved on: 
Friday, November 17, 2023
Hypertension, NYSE, Prevalence, RDN, Medtronic, Coronary, HTN, Patient, FDA, Kidney, Internal medicine, Stroke, University, Death, Hyperkinesia, Physician, Blood pressure, Pharmaceutical industry, Medicine

DUBLIN, Nov. 17, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.

Key Points: 
  • Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, and its prevalence is notably worse in underserved U.S. populations.
  • These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.
  • The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension."
  • The Medtronic Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure.

Surmodics Announces Launch of Preside™ Medical Device Coating Technology, Providing Industry-Leading Lubricity and Durability to a Broader Range of Complex Device Applications

Retrieved on: 
Tuesday, October 31, 2023
Health, Chemicals, Plastics, Medical Devices, Manufacturing, General Health, Cardiology, Biotechnology, Senior, Physician, Environment, Friction, Peripheral, Coronary, Sizing

Surmodics, Inc. (NASDAQ: SRDX), the global leader in medical device coating technologies, announced the commercial launch of its most advanced hydrophilic medical device coating technology, Preside™ hydrophilic coatings.

Key Points: 
  • Surmodics, Inc. (NASDAQ: SRDX), the global leader in medical device coating technologies, announced the commercial launch of its most advanced hydrophilic medical device coating technology, Preside™ hydrophilic coatings.
  • Preside hydrophilic coatings complement Surmodics’ existing Serene hydrophilic coatings by providing customers with a unique low-friction and low-particulate generation coating to further enhance distal access for neurovascular applications, as well as improve crossing for challenging coronary lesions or chronic total occlusions.
  • Surmodics’ Preside hydrophilic coatings allow customers to leverage their existing coating processes resulting in easy implementation in a manufacturing environment.
  • Our Preside hydrophilic coatings strengthen our existing portfolio and sets a new performance standard for the industry, and the medical device manufacturers we serve.”

Supira Medical's Next Generation Percutaneous Ventricular Assist Device (pVAD) System to be Highlighted in a Live Case and Multiple Sessions at the Upcoming TCT 2023 Conference

Retrieved on: 
Friday, October 20, 2023
Exhibition, PDT, Innovation, Interventional cardiology, Use, Physician, Complex, Coronary, Cardiogenic shock, CS, Early, HCPCS Level 2, Coronary artery disease, LOS, Instituto Nacional de Medicina Genómica, Heart Institute, University of São Paulo, Cost, TCT, Paulo, Patient, Medical device, Pharmaceutical industry

LOS GATOS, Calif., Oct. 20, 2023 /PRNewswire/ -- Supira Medical, Inc., a Shifamed portfolio company, announced today that the company's percutaneous ventricular assist device (pVAD) will be showcased in multiple sessions, including a live case presentation, during the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference taking place October 23-26 in San Francisco, CA.

Key Points: 
  • "We are extremely pleased to have the Supira System included in several outlets of the program this year," commented Dr. Nitin Salunke, President and CEO of Supira Medical.
  • "Thank you to the TCT committee for showcasing Supira in a live case presentation where we can demonstrate how our innovative technology's low profile and high continuous flow has the potential to offer significant advantages for physicians and patients requiring hemodynamic support."
  • The live case presentation from the Instituto do Coracao (InCor) in São Paulo, Brazil will take place at 11:45am PDT in the Coronary Theater, Hall F on the Exhibition Level of Moscone North.
  • Following the company's first-in-human experience, Supira Medical has expanded its clinical program, initiating a feasibility study in São Paulo, Brazil.

Alucent Biomedical Wins FDA Approval for U.S. Clinical Study

Retrieved on: 
Wednesday, August 2, 2023
Medical Devices, FDA, Health, Clinical Trials, Cardiology, Biotechnology, PAD, Trial of the century, Standard of care, Patient, Vascular disease, Coronary, Peripheral artery disease, Vascular remodelling in the embryo, Arteriovenous fistula, IDE, AVF, Medical imaging

Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.

Key Points: 
  • Alucent Biomedical Inc. today announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption (IDE) for a U.S. clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
  • AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling.
  • The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow.
  • “IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” said Dr. Myles Greenberg, CEO of Alucent Biomedical.

Medtronic Statement on ESH Guidelines for Hypertension and Renal Denervation

Retrieved on: 
Monday, July 3, 2023
Health, Medical Devices, Surgery, Research, Science, Cardiology, Biotechnology, Blood pressure, GSR, RDN, European Society of Cardiology, Journal, Patient, Coronary, American Journal of Hypertension, Annual general meeting, European Association for Cardio-Thoracic Surgery, ESC, Society, Safety, Pharmaceutical industry, Medtronic, Hypertension

Medtronic is excited by the updated European Hypertension Society (ESH) guidelines that highlight the role of renal denervation (RDN) as part of the hypertension care pathway.

Key Points: 
  • Medtronic is excited by the updated European Hypertension Society (ESH) guidelines that highlight the role of renal denervation (RDN) as part of the hypertension care pathway.
  • The guidelines were announced at the ESH 32nd Annual Meeting and simultaneously published in the Journal of Hypertension .
  • “These new clinical guidelines in Europe reinforce the safety and effectiveness of RDN as a third pillar for difficult to control hypertension – along with lifestyle changes and medication,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business at Medtronic.
  • Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral Renal Denervation System is currently limited to investigational use in the U.S., Japan and Canada.

Paul Pharris Joins Egg Medical

Retrieved on: 
Tuesday, March 14, 2023
Corporation, Corporate Accountability, White Stag Leadership Development Program, Radiation, Hospital, Egg, Physician, Business, Club, Boston, Trust, Coronary, Boston Scientific, Harvard University School of Mining and Practical Geology, Pharmaceutical industry

ARDEN HILLS, Minn., March 14, 2023 /PRNewswire/ -- Egg Medical, Inc ., a medical technology company committed to reducing scatter radiation exposure during interventional angiographic procedures, is excited to announce that Paul Pharris will be joining the Company as the Chief Revenue Officer and VP of Sales and Business Development.

Key Points: 
  • ARDEN HILLS, Minn., March 14, 2023 /PRNewswire/ -- Egg Medical, Inc ., a medical technology company committed to reducing scatter radiation exposure during interventional angiographic procedures, is excited to announce that Paul Pharris will be joining the Company as the Chief Revenue Officer and VP of Sales and Business Development.
  • Paul brings an extensive track-record of success in medical technology and will report to the Chief Commercial Officer, Gavin Philipps.
  • "We are thrilled to have Paul join Egg Medical.
  • Prior to Joining Egg Medical, Paul most recently served as the Vice President of U.S.

Align Technology Appoints Karim Boussebaa, EVP and MD of iTero Scanner and Services Business—Yuval Shaked to Leave Align End of 2023

Retrieved on: 
Wednesday, February 8, 2023
Electronic Design Automation, Medical Devices, Health, Technology, Dental, Software, Structural heart disease, Align, Align Technology, Electro, Coronary, Philips, NIRI, Family, GE HealthCare, Itero de la Vega, Growth, Mammography, Surveying, Management, Neurovascular bundle

He will remain with Align and continue as a member of Align Technology President and CEO Joe Hogan’s staff supporting strategic initiatives and programs through 2023.

Key Points: 
  • He will remain with Align and continue as a member of Align Technology President and CEO Joe Hogan’s staff supporting strategic initiatives and programs through 2023.
  • Mr. Shaked will transition his role to Karim Boussebaa, who will join Align on February 27 and assume the role of executive vice president and managing director of iTero scanner and services, effective immediately.
  • I want to thank Yuval for his tremendous contributions and leadership of the iTero scanner and services business.
  • Commenting on Mr. Boussebaa’s new position, Align Technology President and CEO Joe Hogan said, “I am very excited to have Karim join Align.

Concept Medical granted Investigational Device Exemption (IDE) approval for their Magic Touch Sirolimus Coated Balloon for the treatment of Below the Knee (BTK) Arterial Disease

Retrieved on: 
Monday, February 13, 2023
Sirolimus, CE, Physician, CMI, Artery, III, Gold, PMA, Safety, Coronary, Columbia University, Patient, Hospital, Magic Touch, Stent, Investigational device exemption, Clinical trial, IDE, Columbia University Irving Medical Center, Debate, RCT, Paclitaxel, Sengkang General Hospital, PAD, OUS, Sengkang, BTK, Isabella Tree, Medical device, Pharmaceutical industry, Moyamoya disease, POBA

TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9thFebruary 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.

Key Points: 
  • TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9thFebruary 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon.
  • The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease.
  • CMI received their first IDE approval for their Magic Touch Sirolimus Coated Balloon for the Coronary ISR indication earlier in September 2022.
  • The Magic Touch PTA Sirolimus Coated Balloon Catheter has also been granted with a breakthrough device designation in BTK by the US FDA.