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BioWorld - Wednesday, December 31, 2025
Home » Topics » Disease categories and therapies » Cardiovascular

Cardiovascular
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Heart and DNA
Cardiovascular

FDA clears Tenaya Therapeutics’ IND for gene therapy product candidate

Oct. 27, 2023
Tenaya Therapeutics Inc. has received clearance from the FDA of the company’s IND application to initiate clinical testing of TN-401.
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Boston Scientific Corp.’s Watchman Flx device
TCT 2023

With Amulet or Watchman, 50% of patients still leak either way

Oct. 26, 2023
By Annette Boyle
Left atrial appendage (LAA) occlusion procedures are designed to reduce the risk of thromboembolism in patients who have non-valvular atrial fibrillation, but a study presented at the 2023 Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco demonstrated that about half of patients continue to have LAA leaks – and potentially the risk of dangerous blood clots and stroke – a year after the procedure.
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Boston Scientific Corporation AGENT Drug Coated Balloon
TCT 2023

Agent could break the code for FDA DCB approval in in-stent restenosis

Oct. 26, 2023
By Annette Boyle
The EU approved the first drug-coated balloon for treatment of in-stent restenosis nearly a decade ago, but U.S. physicians continue to have their hands tied in treating the fairly common problem. Results from Boston Scientific Corp.’s investigational device exemption trial for its Agent paclitaxel-coated balloon presented in San Francisco at Transcatheter Cardiovascular Therapeutics could finally put the tool in the hands of cardiologists. The device demonstrated a nearly 50% reduction in the risk of target lesion revascularization and target vessel myocardial infarction compared to conventional balloon angioplasty.
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BMS pays $350M up front for rights to Lianbio’s heart drug Camzyos in Asia

Oct. 25, 2023
By Marian (YoonJee) Chu
American pharma giant Bristol Myers Squibb Co. (BMS) will pick up the rights to Lianbio Co. Ltd.’s FDA-approved drug for obstructive hypertrophic cardiomyopath, Camzyos (mavacamten), in six Asian countries by paying $350 million up front and waiving some outstanding payments.
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Vivio System

Ventric gets FDA clearance for heart failure diagnosis system Vivio

Oct. 25, 2023
By Shani Alexander
Ventric Health Inc. received U.S. FDA 510(k) clearance for its Vivio system, a mobile, non-invasive medical device that can aid in the diagnosis of heart failure. With early diagnosis crucial for treating and managing the condition, Vivio uses advanced algorithms to detect elevated left ventricular end diastolic pressure (LVEDP) in less than five minutes and can therefore improve clinical and health outcomes.
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Ekos Flotriever
TCT 2023

Real-world study: Less bleeding with Ekos than Flowtriever in PE

Oct. 25, 2023
By Annette Boyle
An analysis of real-world data pulled from Truveta’s electronic health records of 30 U.S. health care systems found that patients treated for pulmonary embolism (PE) using Boston Scientific Corp.’s Ekos endovascular system had lower rates of adverse events, particularly intracerebral hemorrhage, than those treated with Inari Medical Inc.’s Flowtriever system.
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Anteris Duravr
TCT 2023

Anteris provides update on biomimetic valve for aortic stenosis

Oct. 25, 2023
By Annette Boyle

Anteris Technologies Ltd. presented multiple sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 annual meeting in San Francisco this week on its novel Duravr biomimetic heart valve, a balloon-expandable, single-piece transcatheter aortic valve designed to closely replicate the shape and performance of a human aortic valve. The device was used for the first time earlier this year in a valve-in-valve replacement procedure and began its early feasibility study, both of which were reviewed at the cardiology meeting.


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Obesity and heart disease illustration
TCT 2023

OCT, IVUS look the same for guiding PCI procedures

Oct. 24, 2023
By Annette Boyle
No matter how you look at it, guiding percutaneous coronary interventions to treat complex lesions with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) produces similar results in patients with complex lesions, a study presented Oct. 23 at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco indicated.
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Illustration of Aurora EV-ICD in chest
TCT 2023

Edwards, Medtronic likely to gain a beat on competition at TCT

Oct. 23, 2023
Medtronic plc got a jump on its cardiology competitors with big news ahead of the Transcatheter Cardiovascular Therapeutics (TCT) conference that starts on Oct 24 in San Francisco, with U.S. FDA approval of its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD). The system delivers defibrillation and heart pacing without placing wires in the heart or vasculature. That puts it in direct competition with Boston Scientific Corp.’s Emblem S-ICD, currently the only player in the market.
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Cardiovascular illustration

Diving into CVD? Novo Nordisk to acquire KBP’s hypertension drug for $1.3B

Oct. 17, 2023
By Marian (YoonJee) Chu
Danish obesity and diabetes drugmaker Novo Nordisk A/S is set to acquire the Singapore-based KBP Biosciences Co. Ltd.’s hypertension drug, ocedurenone (KBP-5074), for potentially $1.3 billion, creating a platform to increase its reach in the cardiovascular (CV) landscape beyond a crowding obesity market.
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