Teleflex Inc. received favorable results for a multi-center study reaffirming the safety and effectiveness of its UroLift System. The Wayne, PA-based company said the results were published in the Journal of Endourology.
The multi-center, retrospective study examined the results of 1,413 consecutive patients who received the UroLift System for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The trial took place over the course of two years across 14 sites in North America and Australia.
Data published from the study show that patients from multiple subgroups treated with the UroLift System experienced improvements in IPSS (International Prostate Symptom Score) and QoL (Quality of Life) score:
- Consistent with the pervious L.I.F.T. study, symptoms improved significantly from baseline at all follow up time points through two years, and most perioperative adverse events were mild to moderate, resolving by four weeks
- In a cohort-matched comparison to L.I.F.T. study patients with moderate-severe symptoms (IPSS ≥13), symptom improvement was similar at all time points
- Of the 165 patients in retention at baseline, 83% became catheter-free by one-month post-procedure and 87% were catheter-free by the end of the study; IPSS scores were similar to non-retention patients
- In the 73 patients with prior prostate cancer treatment, mean IPSS improved at all time points with no significant difference in adverse events of interest compared to other patients
- IPSS improvement was similar regardless of prostate volume (< 30cc; 30cc to <80cc; ≥80cc)9
“Not only are the real-world results from this large, multi-center study consistent with the L.I.F.T study, this study also provides data in populations of patients who were not studied in the L.I.F.T study but are seen in a real-world clinic setting,” said Gregg Eure, MD, urologist at Urology of Virginia in Virginia Beach, Virginia, a lead investigator and co-author of the study. “These findings should give urologists and patients the confidence to adopt the UroLift System within the broader BPH population.”
UroLift is a minimally invasive technology cleared by FDA, for treating lower urinary tract symptoms due to BPH. The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.
Boston Scientific has a competing technology in the BPH market in the form of the Rezūm system. The Marlborough, MA-based company picked up the device when it acquired NxThera for about $406 million, during a busy deal-making period.
Teleflex has also been pretty active in the M&A department over the past few years. In October of last year, the company announced it was picking up Essential Medical to help bolster its presence in the structural heart market. Essential Medical’s MANTA Vascular Closure device is designed for the closure of large bore arteriotomies following procedures utilizing devices or sheaths ranging in size from 10F to 18F.
About two years ago, Teleflex acquired NeoTract for up to $1.1 billion. NeoTract had developed a system delivers permanent implants designed to hold open the urethra in order to reduce the prostate obstruction without cutting, heating, or removing prostate tissue.
Seven months prior to the NeoTract deal, Teleflex completed its $1 billion acquisition of Vascular Solutions.