Regulatory

Varian Medical Systems has received FDA 510(k) clearance for its updated ProBeam™ proton therapy system which the company claims minimizes proton therapy dose to healthy tissues that surround cancers.

Israeli device company MediValve has announced the FDA clearance and CE mark approval of its acWire™ Guidewire, intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices.

Edwards Lifesciences’ new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of four to eight percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a SAPIEN 3 valve.

So-called transendocardial delivery of stem cells has solid clinical evidence supporting it. And now it has a newly CE marked catheter that opens up the procedure to patients with enlarged, dilated hearts, widening the pool of patients who can benefit from the therapy.

TAVI developer Direct Flow Medical®, Inc., has received CE Mark for the first fully repositionable 29mm transcatheter aortic heart valve in the same week that the company has announced completion of enrollment in its US feasibility trial in patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement.

As financial pressures mount, automated bedside patient monitoring should really provide reassurance that patient care won’t drop through the cracks. New enhancements to the EarlySense system deliver more monitoring options, including respiration, heart rate and motion.

K2M, Inc., has received 510(k) clearance from the US FDA to market CAYMAN® Minimally Invasive, the latest addition to the company’s CAYMAN product family of plate systems already featuring CAYMAN Anterior, CAYMAN Buttress and CAYMAN Lateral .

Sinus Health company SinuSys™ Corporation has announced the FDA clearance for its Vent-Os™ Sinus Dilation System, which it will start to commercialize immediately in select markets in the U.S.

The Modular PMA means companies can submit their data sequentially to the FDA en route to ultimate approval. Sapheon has reached stage 2 with its Venaseal varicose vein treatment system.

Smiths Medical says its newly cleared CADD®-Solis pain management system combines Patient controlled and Programmed Intermittent Bolus deliveries for labor analgesia and post-operative pain management

Endologix, Inc., has received Investigational Device Exemption (“IDE”) approval from the US FDA to begin a pivotal clinical trial to evaluate the safety and effectiveness of its Nellix® EndoVascular Aneurysm Sealing System (“EVAS”) for the endovascular repair of infrarenal abdominal aortic aneurysms.

It’s all happening at InVivo Therapeutics. In a flurry of news releases the company has appointed a new CEO, gained conditional approval to commence its US trial and gone ahead and satisfied the conditions with a series of responses to the FDA’s outstanding issues. The study will commence with first patients in early March.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.

Baxter International Inc. has gained CE mark approval for its VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy.

The U.S. FDA has allowed Xlumena’s AXIOS Stent onto the market under its de novo pathway. AXIOS is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.

Reverse Medical® Corporation has announced CE Mark approval for its BARREL® Vascular Reconstruction Device (VRD) and the first European clinical case. The BARREL® Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.