New Products: BPH surgical robot granted FDA de novo request

BPH surgical robot granted FDA de novo request

The FDA has granted a de novo request for PROCEPT BioRobotics’ AquaBeam System for the resection and removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) as a result of BPH. The system, which delivers Aquablation therapy, is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH, according to the company. Commercial access to the U.S. market was supported by the results of the global WATER (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) study, a 181-patient, double-blind, randomized clinical trial comparing Aquablation therapy with the AquaBeam System with transurethral resection of the prostate (TURP) for the treatment of LUTS caused by BPH. When compared to TURP, Aquablation therapy demonstrated equivalent efficacy outcomes with a superior safety profile, including a reduction in sexual side effects by a ratio of four to one. The system will be commercially available in the U.S. in early 2018.

For more information, visit www.procept-biorobotics.com.

Silicone-based plates launched for study of catheter infections 

Fluxion Biosciences has launched a new BioFlux plate for studying infections caused by the long-term use of catheters. The new plates provide a convenient model for the study of bloodstream and urinary tract infections associated with catheters and can serve as a platform for the development of preventive approaches, the company said. The new silicone-based plates are available in both 24- and 48-well configurations, and are compatible with all BioFlux system configurations.

For more information, visit www.fluxionbio.com.

Medicare Administrative Contractor extends coverage of OAB treatment 

Cogentix Medical, Inc. announced that Medicare Administrative Contractor Palmetto GBA, LLC, has extended its coverage policy for percutaneous tibial nerve stimulation (PTNS) to allow patients with overactive bladder (OAB) symptoms to receive ongoing maintenance treatments for up to 3 years. Patients with Medicare coverage in North Carolina, South Carolina, and most of Virginia and West Virginia can continue to receive the benefits of PTNS therapy delivered by Cogentix Medical’s Urgent PC Neuromodulation System for their OAB symptoms for an additional year, Cogentix Medical said. 

For more information, visit www.cogentixmedical.com.

Pre-lubricated intermittent catheter for men launched

Cure Medical has unveiled the new 16-inch Cure Ultra Coude Intermittent Catheter for men who are seeking an easy-to-use, pre-lubricated catheter that will not kink when it is bent. The sterile, single-use Cure Ultra Coude intermittent catheter for men comes in sizes 12F to 18F and features an easy tear top, fire-polished eyelets, pre-lubricated straight tip, easy gripper sleeve for better control, and a blue control stripe for accuracy in insertion.

For more information, visit www.curemedical.com.

Incontinence products to feature breathable technology 

TENA recently announced that its Premium Briefs, Protective Underwear, and Heavy Pad incontinence products will now feature TENA ConfioAir 100% breathable technology, which allows excess moisture to evaporate to help maintain skin’s natural moisture balance and improve comfort for wearers. TENA’s ConfioAir technology features a unique outer layer with micro-pores that allows moisture from the inner absorbent core to evaporate. This helps maintain skin’s natural moisture balance, allowing it to breathe and keeping the skin on the inside of the product comfortable and dry, according to the company. ConfioAir technology is now included across TENA’s premium absorbent product line.

For more information, visit www.tenaprofessionals.us.

FDA approves new indication for renal cell carcinoma treatment

The FDA has approved a new indication for sunitinib malate (SUTENT), expanding its use to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. Pfizer said the approval was based on results from the S-TRAC trial that demonstrated a significant reduction in the risk of a disease-free survival event (defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause) for patients at high risk of RCC recurrence who received SUTENT compared to placebo in the adjuvant setting. SUTENT had been previously approved for the treatment of advanced renal cell carcinoma. 

For more information, visit www.pfizer.com.

Generic versions of erectile dysfunction treatment launched

Greenstone LLC and Teva Pharmaceutical Industries Ltd. are each launching generic versions of Viagra tablets (sildenafil citrate) in the U.S. Greenstone said its version of the erectile dysfunction drug will be available in strengths of 25 mg, 50 mg, and 100 mg. Teva said it is offering wraparound services to support patients, such as a sildenafil tablets savings card with which people who meet certain requirements are eligible to participate in the program and may pay as little as $0 out of pocket with a maximum benefit of up to $100 per fill, for up to six sildenafil tablets prescriptions. 

For more information, visit www.greenstonellc.com and www.tevausa.com.

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