Approval/Clearance

So, a drug eluting stent which doesn’t rely on a polymer coating to carry the drug. Clever. And now CE marked in the form of BioFreedom from Biosensors International.

Gore launches a new sheath design in Europe, which it says delivers easier insertion and removal of endovascular devices for AAA and TAA.

Varian Medical Systems has received FDA 510(k) clearance for the company’s Edge™ radiosurgery suite, a new dedicated system for performing advanced radiosurgery using innovative real-time tumor tracking and motion management technologies.

Medtronic, Inc. has announced the CE mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically the superficial femoral arteries and proximal popliteal arteries.

Varian Medical Systems has gained FDA 510(k) clearance for the latest version of its Vitesse™ real time planning for high dose rate (HDR) brachytherapy which is used to plan and perform HDR, ultrasound-guided brachytherapy treatments for prostate cancer.

Neurodevice firm SPR Therapeutics has received the CE mark for its Smartpatch system, a peripheral nerve stimulation (PNS) therapy for the minimally-invasive treatment of pain. The first indication to receive CE certification is chronic shoulder pain.

Covidien has gained CE Mark approval for its EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System which it says is designed to allow physicians to consistently place stents in the desired location with accuracy and ease.

Diagnostic device company Welch Allyn, has received FDA 510(k) clearance to market its iExaminer™ iPhone compatible image capture system that allows healthcare providers to capture, store, send and retrieve images from the Welch Allyn PanOptic™ Ophthalmoscope using the iPhone® 4 or 4S.

Infrascan gained FDA approval in late 2011 for its noninvasive haematome detection device. Now, as is the way of things, version 2 has gained the agency’s nod, featuring a more “ruggedized” build for military and other field operations.

Zimmer has received FDA 510(k) clearance to market iASSIST™ Knee, the Personalized Guidance System™ for knee replacement procedures. Zimmer says its device provides simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment.

U.S. medtech company Integra has received European CE Mark Certification for its Integra® Flowable Wound Matrix, which it describes as an advanced device for filling deep soft tissue or tunneling wounds, including diabetic foot and leg ulcers.

Occlusion of the Left Atrial Appendage has become a recognised preventative measure in the AF patient, this anatomical feature being the source of the majority of clots. Now occlusion has been made easier with the CE marking and introduction of a next generation device from St.Jude Medical, Inc.

St. Jude Medical, Inc. has gained U.S. FDA approval for its next-generation Merlin.net™ Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

Gore has received FDA approval to extend its AAA range to include a new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components, as well as the lower profile 31 mm diameter trunk-ipsilateral leg and 32 mm aortic extender components of the GORE® EXCLUDER® AAA Endoprosthesis.

Drug resistant depression is a problem with a new solution in the U.S. now that the FDA has given Brainsway’s non invasive magnetic stimulation device the nod.

Olive Medical Corporation of Salt Lake City, has announced FDA 510K clearance and the worldwide sales launch for the OVS1 All-in-one HD Visualisation system.