Urology

The UK’s National Institute for Health and Clinical Excellence (NICE) has issued Interventional Procedure Guidance (IPG) approving the UroLift prostatic urethral lift implant for use by UK doctors. The result should mean fewer side effects or complications compared with the traditional TURP procedure.

American Medical Systems® Inc. (AMS), has announced that its RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI) has gained CE Mark approval.

Medtech Market Intelligence company Millennium Research Group (MRG), has launched a new report which looks into the future for laparoscopic surgery devices in the United States. MRG believes the market will see moderate growth, culminating with a market value of $4.5 Billion by 2022.

Robot-assisted surgery is under the spotlight again as one research company claims the adoption of Intuitive Surgical’s daVinci system is riddled with flaws. Citron Research urges intuitive to “stop one-sided and misleading marketing to patients, without full disclosure of the risks”.

Following the announcement of the FDA clearance of NeoTract’s UroLift® System for treating symptoms of benign prostatic hyperplasia, the company has issued a press release confirming that a first patient has now undergone treatment with the device.

NeoTract, Inc., has received De Novo approval from the U.S. FDA to market the novel UroLift® System, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with Benign Prostatic Hyperplasia, also known as enlarged prostate.

Cook Medical has a new device which it says simplifies percutaneous nephrolithotomy procedures, during which physicians break up and remove large kidney stones. LithAssist™ combines suction control and provides access for a laser fiber and is the first device globally to provide suction control and laser fiber access.

MIS device company AngioDynamics has announced the U.S. FDA’s Investigational Device Exemption (IDE) approval to conduct a clinical study of the NanoKnife System for the ablation of focal prostate cancer.

CryoLife, Inc. has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the US FDA. PerClot is an absorbable polysaccharide hemostat, intended for adjunctive use in surgical procedures when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical.

The only FDA approved ureteral access sheath that has two options for placement is now available in the United States. The Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath allows urologists to use a single wire guide that functions as both a working wire and a safety wire.

Vaginal Tape and Mesh problems continue to exist. UK competent authority the MHRA has issued a new document which endeavours to capture the state of play and provide guidance for surgeons in the NHS.

Norwegian company Vitacon has announced the FDA 510(k) clearance of its clever non-invasive bladder scanner, which seems to tap into new reimbursement guidelines. The company has employed a U.S. partner to drive its commercialisation efforts.

Voiding dysfunction device company Uroplasty Inc. tells us that positive results from a long-term clinical pilot study using an implantable tibial nerve stimulation device will be presented at the Annual Meeting of the International Continence Society.

Zynex, Inc., a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device which is designed to aid in the treatment of female urinary incompetence.

A “Talking” Blood Glucose Meter that doesn’t talk. A sterile urinary catheter that isn’t sterile. A reprocessing unit that risks contaminating its contents. A week in the life of UK MHRA’s safety/recalls/alerts department.

Canadian device company Covalon Technologies Ltd., is showing its wares at the AUA 2012 even in Atlanta, not the least of their offerings being the new SilverCoat™ antimicrobial silicone foley catheter with its UTI busting credentials.