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Letter to the Editor Re: Langston® Dual Lumen Catheter Reintroduction
Re: Langston® Dual Lumen Catheter Reintroduction
Nearly 18 months have passed since Teleflex made the decision to voluntarily recall Langston® Dual Lumen Catheters. A cluster of inner-member separations occurring during power injections had been reported, and readers may recall one illustrative example being circulated in social media. Thankfully, there were no reports of patient injury, but the potential clearly existed. Thus, the decision by Teleflex to withdraw the product worldwide was swift and unquestioned.1
Following the recall, a thoughtful editorial in Cath Lab Digest lamented the temporary gap invasive cardiologists faced for obtaining safe, accurate, procedurally simple, and cost-sensible measurements of valve gradients during hemodynamic studies. The principles of high-fidelity, simultaneity, freedom from reflected waves and pressure recovery, and single radial or femoral access were emphasized, and a variety of historic and innovative methods that approached these goals were described. All of these workarounds, however, involved one compromise or another.2
It is in this context that Teleflex is pleased — and relieved — to return the Langston® Dual Lumen Catheter to market. By the time this letter is in print, the Langston® catheter will have been distributed to cath labs around the United States. Re-introduction worldwide will follow as quickly as local regulatory processes allow. Teleflex is grateful for the patience our customers have shown over the past eighteen months as our sales team fielded countless inquiries. It has taken time to understand the cause, durably correct it, and validate that correction with the certainty required both internally and by regulators. Therefore, we want to take this opportunity to simply say thank you. The wait is over.
References
1. Buller CE. Letter to the Editor Re: Langston – Clinical Editor’s Corner. Cath Lab Digest. 2021 Apr; 29(4): 44. Accessed August 11, 2022. https://www.hmpgloballearningnetwork.com/site/cathlab/content/letter-editor-re-langston-clinical-editors-corner
2. Kern MJ, et al. The Langston is gone for now (no more dual lumen pigtail for aortic valve assessment). Now what? Cath Lab Digest. 2021; 29(4): 6-10. Accessed August 11, 2022. https://www.hmpgloballearningnetwork.com/site/cathlab/content/langston-gone-now-no-more-dual-lumen-pigtail-aortic-valve-assessment-now-what-includes-video-discussion
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Commentary Re: Langston® Dual Lumen Catheter Reintroduction
It is with pleasure that I read the above letter by Chris Buller of Teleflex and note with relish the return of the Langston Dual Lumen catheter to our labs. While anxiously awaiting its delivery, I want to remind us that the best and most often used methods in medicine are those that are efficient, accurate, and cost effective. For cath lab procedures, ease of use and set-up makes for efficiency. Good hemodynamic fidelity and reliability makes for best accuracy. Cost is the easiest one to figure out. These features make the return of the Langston catheter the most valuable member of the group of techniques to measure left ventricular-aortic (LV-Ao) gradients (See the CLD Editor’s Corner discussing what we did when the Langston was on hold1).
The story of the Langston catheter’s recall and reintroduction is a real demonstration of our industry partner’s safety and good management. Teleflex should be commended for a job well done in identifying the problem, doing the detailed root cause analysis, and implementing the improvements, leading to the FDA green light for reintroduction to the market in record time. Kudos.
As an aside for those interested, there is a webinar and session on the best hemodynamic approaches to the assessment of aortic stenosis at TCT Boston, on September 18, 2022. I look forward to getting back to work with one of my favorite hemodynamic products.
Reference
1. Kern MJ, et al. The Langston is gone for now (no more dual lumen pigtail for aortic valve assessment). Now what? Cath Lab Digest. 2021; 29(4): 6-10. Accessed August 11, 2022. https://www.hmpgloballearningnetwork.com/site/cathlab/content/langston-gone-now-no-more-dual-lumen-pigtail-aortic-valve-assessment-now-what-includes-video-discussion