The UroLift System, from NeoTract, Inc. (Pleasanton, CA), discussed below, is really a perfect example of how medical device technology is often very symptom-, rather than disease-oriented. Medical technologies frequently address a narrow clinical need without regard to the actual disease that caused it. Manufacturers have been driven by market demand to pursue well defined clinical needs that are solved by specific innovations. In the UroLift example, the fundamental problem is the enlarged prostate's constriction of the urethra, limiting its diameter and impeding normal urinary flow. TheUroLift System solves the immediate problem of the constricted urethra without addressing the hypertrophy in the prostate or its potential to evolve into prostate cancer.
This is succinctly why medical device technologies succeed while not being necessarily tied to long-term outcome.
This is quite analogous to coronary angioplasty, which obviated the need for coronary bypass, until high rates of restenosis or the reocclusion of vessels drove the manufacturers to augment angioplasty with stenting; that is, until stubborn levels of post-stent restenosis led to the development of drug-eluting stents, which, in some cases, led to late-stage restenosis. Medtech whack-a-mole.
Devices often succeed at solving limited functional problems, without particular regard to the long term outcome. They satisfy demand for symptomatic solution. This is not a judgment against medical devices, since in lieu of the availability of approved treatment that targets the root cause of disease, specific symptoms may represent either real, often life-threatening, conditions (e.g., coronary ischemia) or conditions that significantly challenge quality of life.
Before reaching the conclusion that medical technologies should only focus on long-term outcomes or on life-threatening conditions, be prepared to tell the man with BPH that solving his urinary flow problem is not an outcome sufficient in and of itself. Therein lies a big challenge in healthcare.
No Ablation, No Resection: Minimally Invasive UroLift System Goes on Trial in US
The trial of UroLift System, a device being developed by a Pleasanton, California based NeoTract, Inc., has now been initiated in the US, according to the company. The minimally invasive technology is designed to treat lower urinary symptoms of benign prostatic hyperplasia (BPH) by opening the urinary pathway by retracting hyperplastic urethral tissue without applying incisions, surgical resection or thermal injury to the prostate.
From the product page:
1. The UroLift delivery device is inserted transurethrally through a rigid sheath (not shown) under cystoscopic visualization to reach the targeted area of obstruction.
2. UroLift sutures are deployed through a needle that comes out of the delivery device to retract the obstructing lobes.
3. The UroLift delivery device and sheath are removed, leaving an expanded urethral lumen.
UroLift System Treatment Highlights:
•Endoscopic results can be immediately confirmed post-procedure.
•The procedure may be performed under local anesthesia.
•Some patients can avoid any catheterization
•Patients may experience symptom relief as early as 2 weeks post-procedure.
•There have been no reports of new onset of sexual dysfunction, retrograde ejaculation or permanent erectile dysfunction.
• UroLift system treatment does not preclude the option for future TURP should one be indicated
Press release: NeoTract Announces First U.S. Patients Enrolled in Study of New Minimally Invasive Device for Benign Prostatic Hyperplasia …
Product page: UroLift® System …
Video animation of the procedure …