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
QuikClot, Titan, and UroLift. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
QuikClot Control+ - FDA Regulatory Timeline and 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.
- 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.
Read Announcement
Titan SGS - FDA Regulatory Timeline and 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.
- 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.
Read Announcement
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.
- 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.
Read Announcement- 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.
Read Announcement- Drug:
- UroLift
- Announced Date:
- May 7, 2024
- Indication:
- Men with benign prostatic hyperplasia (BPH)
Announcement
Teleflex Incorporated announced the presentation of new research findings from the 2024 American Urological Association Annual Meeting in San Antonio, TX, May 3 – 6, 2024, showcasing excellent patient experience* with the Prostatic Urethral Lift (PUL) with the UroLift™ System for benign prostatic hyperplasia (BPH).
Read Announcement
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