New St. Jude Tacticath Contact Force Catheter approved for AFIB ablation in US by FDA

St Jude's 'Tacticath' Contact Force catheter

This is a head's up on FDA approve this past week for the St Jude's Medical Tacticath Contact Force catheter which now joins the already approved earlier this year Biosense Webster Thermocool Smart-Touch contact force catheter and now providing two such clever options for EPs to choose from and both of which can really help improve ablation results via more consistent transmural lesion creation.

these tools can help everyone from the most experienced to the greenhorn EP, but should really help raise the bar in particular for the more typical EPs who may have struggles to achieve consistency in their results with lower levels of reconnections as the cause for a good many of their repeat ablations needed.

Its good news in any event as the Tacticath has some very clever design features that make it a excellent choice.

Shannon

Thanks Shannon...Awesome

Hi Shannon, it will be nice for the EPs to have another choice. This Tacticath clearance also point out the strangeness of the FDA when it comes to evaluate medical devices. I use the word "strangeness" instead of "corrupted process" in deference to the hard working scientists there. The tacticath uses fiber optics (3 fibers thinner than hair thin) to measure force and deflection to very high accuracy. Something that's already been done for many years now in other industrial applications. Yet the FDA required them to go through the PMA process which takes an order of magnitude higher level of clinical trials to get it cleared compared to the 510K route that JNJ was allowed to go through which is much less rigorous. Springs have potentially many more mechanical issues (like falling apart) compared to fibers inside the body of a catheter. There are other examples that make me shake my head about the FDA. Yes, it does matter which consultants were hired to work with the FDA and how much is spent on soft lobbying. That's how trials get done and why doctors push device trials with patients that are compliant. The bonus money is good. End rant.

Yep Researcher the hoops and nonsense that often companies and patients have to go through 'for our own protection' gets pretty silly at times, and very costly too in terms of time, money and often slowing down beneficial tools for docs and patients a like.

A lot of politics involved too with this much money at stake.

Shannon

Related to this topic. I received an emailer today from EP Lab digest with a direct ad campaign from St Jude Medical- There is a graphic that goes before the "what exactly does that mean? paragraph. That didn't cut and paste. If interested, check out STJ's website and look up tacticath.

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The TactiCath™ Quartz Ablation Catheter provides contact force-sensing information, which is a significant component of lesion formation. St. Jude Medical is the first to provide contact force (CF) management guidelines to optimize lesion quality for atrial fibrillation (AF) ablation backed by clinical publications. While the quality of lesions formed using radio frequency (RF) is dependent on many factors, including power delivered and duration of energy application, the TactiCath Catheter provides you the ability to monitor contact force and fine-tune the pressure to target specific parameters during AF procedures.1-3 The TOCCASTAR protocol-specified descriptive endpoint analysis resulted in an 85.5% clinically relevant success using optimal CF (≥ 90% lesions ≥ 10 g) at the end of 12 months.4 In addition, recommendations proven by St. Jude Medical are as follows:


What exactly does that mean?

When < 20 g of CF has been targeted, patients have a lower chance of success. When > 20 g is targeted, there isn’t any additional benefit.
< 10 g of CF is ineffective at creating effective lesions, which can result in edema.
An FTI™ < 400 gs is ineffective at creating effective lesions.
If you ablate one spot with 10 g of CF unsuccessfully, then try again later with 20 g of CF, an effective lesion wouldn’t be created due to edema from the first attempt.