Boston Scientific shares positive drug-coated balloon data

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + announced positive data from a trial of its Agent drug-coated balloon (DCB).

The Marlborough, Massachusetts-based company presented its results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting. Data demonstrated statistical superiority for Agent compared to uncoated balloon angioplasty.

AGENT IDE evaluated the safety and effectiveness of using a DCB to treat coronary in-stent restenosis (ISR). The paclitaxel-coated balloon catheter offers an alternative to treatments like stent layering or radiation. It’s designed to re-open vessels and transfer the therapeutic drug to the vessel wall, helping to prevent ISR reoccurrence.

The Agent DCB has FDA breakthrough device designation.

Boston Scientific set a primary endpoint of target lesion failure at 12 months. Agent DCB topped balloon angioplasty with 1…

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Recor Medical presents more data supporting its renal denervation system

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat. [Image courtesy of Recor Medical]Otsuka Medical Devices’ Recor Medical announced another set of positive study results for its Paradise ultrasound renal denervation (uRDN) system.

A combined analysis of six-month follow-up data from three RADIANCE global studies evaluated Paradise as a hypertension treatment. The analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN compared to sham. It also saw fewer antihypertensive treatments added in the treatment group.

The data provides further support for the renal denervation system, which looks the most likely to garner the first FDA nod for treating hypertension. An FDA panel in Au…

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PCI guidance tech from Philips delivers positive study results

iFR technology. [Image courtesy of Philips]Philips (NYSE: PHG) + today announced study results supporting its instant wave-free ratio (iFR) in guiding percutaneous coronary intervention (PCI).

Amsterdam-based Philips offers iFR as a pressure-derived index to assess coronary blockages during interventional procedures. iFR avoids the use of hyperemic agents — drugs that maximize blood flow but can impact the patient experience.

Dr. Matthias Götberg presented results from a longitudinal analysis at the 35th annual Transcatheter Cardiovascular Therapeutics (TCT) symposium. Götberg works in the Dept. of Cardiology, Clinical Sciences at Lund University, Sweden.

The study looked at the National Swedeheart Quality Registry of more than 42,000 patients undergoing coronary procedures. Results demonstrated no difference between iFR and fractional flow reserve (FFR) in major adverse cardiac events (MACE).

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The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

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