Products

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.

Oh dear, medtech industry body is really not sounding happy at the European Parliaments rushed through rule changes. And when they point to the huge cost and delay to market that will result from a bureaucratic behemoth, who are we to argue?

It’s a clever concept, the idea that by doing some assembly at the surgical site the physician can avoid large incisions. Vertebral Technologies’ newly FDA cleared system permits a large lumbar interbody fusion using a minimally invasive approach.

Nitinol staples for extremity fixation are not new, but this one, from Solana Surgical, requires no heat to activate its compressive qualities and is presented in a single-use, all-inclusive sterile pack, which avoids sterile processing and liability costs for the healthcare provider.

Peripheral Vascular Stent options in the US now include Medtronic’s Complete SE offering which has seen its indication extended to include the superficial femoral and proximal popliteal vessels.

Small bowel disease, including Crohn’s, is now within the diagnostic grasp of Gastrointestinal physicians in Japan with the news that Given Imaging’s optimised SB3 PillCam has been approved for market release. Sales will start in 2014.

Edwards Lifesciences’ FDA approval for its Sapien Transcatheter Heart Valve was originally limited to transfemoral or transapical access. Now the access point restriction has been lifted, based on clinical registry data. Whether this opens up the patient population remains to be seen.

Sapheon Inc. has submitted the first module of the pre-market approval application for the VenaSeal® Sapheon Closure System to the U.S. FDA. Sapheon expects to be launching its product in the first half of 2015.

Ocular Therapeutix, developer of hydrogel based sealant technology for use in ophthalmic cases, has received a guarded nod from the FDA’s review panel.

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.

K2M, Inc. is focused on minimally invasive spinal surgery and the development of systems to address complex spinal pathologies. The company has chosen this week’s Scoliosis Research Society’s (SRS) 48th Annual Conference in Lyon, France, at which to announce that it has now entered the spinal device market in France.

Vital Access Corp. has received U.S. FDA market clearance for its patented VWING™ Vascular Needle Guide which has been shown to enable vascular access to arteriovenous fistulas for patients undergoing hemodialysis.

JenaValve’s eponymous TAVI system has seen its CE mark indications extended, making it the only transcatheter valve system approved for the treatment of aortic stenosis and aortic insufficiency.

Who’s responsible for ensuring devices get used correctly, according to manufacturers’ instructions? A new survey suggests companies might have to work harder to educate vascular specialists about how to get best results from peripheral drug-eluting balloons.

Smith & Nephew says the US launch of its broad-spectrum antimicrobial DURAFIBER Ag dressing provides clinicians with a different approach to address bacterial contamination posed by medium to heavily exuding wounds.

Ortho/Spine device company Tyber Medical has gained CE Mark approval for TyPEEK, a proprietary titanium plasma sprayed PEEK interbody system. TyPEEK interbody fusion devices are specifically designed for situations where PEEK alone may not provide the best setting for fusion. Tyber Medical is a supplier of private label implants.