Teleflex (TFX) FDA Approvals

Teleflex's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Teleflex (TFX). Over the past two years, Teleflex has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Freesolve™, BIOMAG™-LL, UroLift, Titan, and QuikClot. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Freesolve™ RMS FDA Regulatory Events

Freesolve™ RMS is a drug developed by Teleflex for the following indication: to Target Lesion Failure (TLF) ratea at 12 months. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Designation Grant - October 22,2026

Breakthrough Device

• Drug: Freesolve™ RMS
• Announced Date: October 22, 2026
• Indication: to Target Lesion Failure (TLF) ratea at 12 months

Announcement

Teleflex Incorporated announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI).

Enrollment Update - June 23,2026

• Drug: Freesolve™ RMS
• Announced Date: June 23, 2026
• Indication: to Target Lesion Failure (TLF) ratea at 12 months

Announcement

Teleflex Incorporated announced the beginning of enrollment in the BIOMAG™‑III Study (NCT07258290), a landmark global study evaluating the Freesolve™ Resorbable Magnesium Scaffold (RMS).

AI Summary

Teleflex Incorporated has begun enrollment in the BIOMAG™‑III Study (NCT07258290), a major global clinical trial of its Freesolve™ Resorbable Magnesium Scaffold (RMS). The study is designed to be the most complete evaluation of the device so far and is planned as a pivotal trial to support future regulatory applications. Freesolve™ RMS is made to dissolve within about 12 months, which may help lower long-term problems that can happen with permanent metal implants. By studying how the scaffold performs in patients around the world, Teleflex hopes to build the strong clinical evidence needed to bring the technology to doctors and patients. The start of enrollment marks an important step in testing this new approach to treating heart disease.

BIOMAG™-LL FDA Regulatory Events

BIOMAG™-LL is a drug developed by Teleflex for the following indication: for the treatment of de novo coronary lesions up to 38 mm. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enrollment Update - October 12,2026

• Drug: BIOMAG™-LL
• Announced Date: October 12, 2026
• Indication: for the treatment of de novo coronary lesions up to 38 mm

Announcement

Teleflex Incorporated announced the successful completion of patient enrollment in the BIOMAG™-LL Clinical Study, evaluating the safety and clinical performance of the Freesolve™ Resorbable Magnesium Scaffold (RMS) in 35 mm and 40 mm lengths for the treatment of de novo coronary lesions up to 38 mm.

UroLift FDA Regulatory Timeline and Events

UroLift is a drug developed by Teleflex for the following indication: Men with benign prostatic hyperplasia (BPH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - May 21,2026

• Drug: UroLift
• Announced Date: May 21, 2026
• Indication: Men with benign prostatic hyperplasia (BPH)

Announcement

Teleflex Incorporated announced the Interventional Urology Business Unit has released new clinical data across two major urological congresses, reinforcing the value of the UroLift™ System and Barrigel™ rectal spacer in improving patient-centered outcomes across benign prostatic hyperplasia (BPH) and prostate cancer care.

AI Summary

Teleflex’s Interventional Urology Business Unit has released new clinical data at two major urology meetings, showing strong patient-centered benefits for its UroLift™ System and Barrigel™ rectal spacer. In the first head-to-head randomized study comparing treatment options for benign prostatic hyperplasia, UroLift showed early advantages such as faster recovery, catheter independence, and preserved sexual function, with benefits lasting through 12 months. This matters because these outcomes can improve comfort and quality of life for patients choosing a minimally invasive treatment.

Teleflex also shared three-year results for Barrigel at a prostate cancer conference. The data showed a sustained reduction in radiation-related gastrointestinal toxicity, supporting the spacer’s long-term role in protecting bowel function during and after radiation therapy. Together, these findings add to the clinical evidence that both products can improve outcomes in BPH and prostate cancer care.

Presentation - May 15,2025

• Drug: UroLift
• Announced Date: May 15, 2025
• Indication: Men with benign prostatic hyperplasia (BPH)

Announcement

Teleflex Incorporated announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System's advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes.1-2

AI Summary

Teleflex Incorporated recently presented new clinical data at the 2025 American Urological Association Annual Meeting in Las Vegas, held April 26–29. The data came from two randomized controlled trials comparing the UroLift™ System with Rezūm and tamsulosin for treating benign prostatic hyperplasia (BPH). Results showed that patients treated with the UroLift™ System experienced higher early satisfaction, quicker symptom relief, and better sexual function outcomes than those receiving Rezūm or taking tamsulosin.

These findings underline the UroLift™ System’s advantages as a minimally invasive BPH treatment, offering a promising alternative to both medication and other minimally invasive approaches. The robust clinical evidence presented supports informed, evidence-based decisions by clinicians and patients aiming for improved quality of life through more effective BPH management.

Findings Update - March 25,2025

• Drug: UroLift
• Announced Date: March 25, 2025
• Indication: Men with benign prostatic hyperplasia (BPH)

Announcement

Teleflex Incorporated announced that new findings from the CLEAR study were presented at the 40th Annual European Association of Urology (EAU) Congress in Madrid, which took place March 21-24, 2025.

AI Summary

Teleflex Incorporated recently presented new findings from the CLEAR study at the 40th Annual European Association of Urology (EAU) Congress in Madrid, held March 21-24, 2025. This landmark study is the first head-to-head randomized controlled trial comparing the UroLift™ System (PUL) with Rezūm™ Water Vapor Therapy (WVTT) for treating symptoms of benign prostatic hyperplasia (BPH).

The study’s results indicated that patients treated with the UroLift™ System experienced faster recovery without catheter use, improved early patient satisfaction, and enhanced sexual function compared to those undergoing Rezūm therapy. Teleflex emphasized that these findings offer valuable, evidence-based insights that support informed treatment choices for BPH. The company’s dedication to advancing research reinforces its commitment to making the UroLift™ procedure a trusted and preferred option for patients in clinical settings and real-life recovery scenarios.

Titan SGS FDA Regulatory Events

Titan SGS is a drug developed by Teleflex for the following indication: laparoscopic sleeve gastrectomy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Publication - May 13,2025

• Drug: Titan SGS
• Announced Date: May 13, 2025
• Indication: laparoscopic sleeve gastrectomy

Announcement

Teleflex Incorporated announced the publication of a new retrospective analysis of clinical data associating the use of the Titan SGS™ Stapler with reduced rates of post-operative GERD following robotic-assisted laparoscopic sleeve gastrectomy (LSG) compared with traditional multi-fire surgical staplers.1

AI Summary

Teleflex Incorporated recently released a retrospective study published in Obesity Surgery showing that the Titan SGS™ Stapler used in robotic-assisted laparoscopic sleeve gastrectomy leads to lower rates of post-operative GERD compared to traditional multi-fire staplers. The analysis of 257 patients found that only 7.1% of those treated with the Titan stapler experienced GERD at one year, compared with 26.4% in the multi-fire group. In addition, the incidence of new (de novo) GERD was reduced, and patients with pre-existing GERD saw better resolution rates. The Titan SGS™ Stapler’s unique 23cm single-fire design helps create a more consistent and symmetrical sleeve pouch, which may prevent kinking along the staple line. Importantly, these improved GERD outcomes were achieved without compromising weight loss, highlighting the device’s potential to enhance post-surgical benefits.

QuikClot Control+ FDA Regulatory Events

QuikClot Control+ is a drug developed by Teleflex for the following indication: Device to of internal and external bleeding. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - April 30,2025

• Drug: QuikClot Control+
• Announced Date: April 30, 2025
• Indication: Device to of internal and external bleeding.

Announcement

Teleflex Incorporated announced U.S. Food and Drug Administration (FDA) 510(k) clearance of an expansion to the Indications for Use of the QuikClot Control+™ Hemostatic Device to include all grades of internal and external bleeding.

AI Summary

Teleflex Incorporated announced that it has received FDA 510(k) clearance to expand the indications for its QuikClot Control+™ Hemostatic Device. Originally approved for specific types of severe internal bleeding and surgical wounds, the device can now be used for temporary control of all grades of internal and external bleeding. This expanded clearance broadens its use beyond trauma to include procedures in general, gynecologic, and orthopedic surgeries, among others.

To support the change, Teleflex presented real-world evidence from a study of 603 emergency, trauma, and surgical patients, showcasing the device’s effectiveness and safety in controlling various levels of bleeding. The expanded indication is expected to improve patient outcomes and add significant market value by targeting more clinical procedures.