Approval/Clearance

InspireMD, Inc., the developer of the MGuard™ Embolic Protection Stent (EPS), has announced approval with conditions for its US FDA Investigational Device Exemption (IDE) application. This approval allows the company to initiate enrollment in the MASTER II IDE trial.

Ventripoint’s right ventricle ultrasound assessment tool was hitherto only CE marked for use in patients with right ventricle-associated disease. Now it can be used in a wider patient cohort, so picking up patients with concomitant heart disease.

Shape memory orthopedic device company MedShape, Inc. has gained US FDA 510(k) clearance for its Eclipse™ Soft Tissue Anchor. The company says its polymer anchor, is designed to attach a tendon, ligament or soft tissue to bone better than screws and other rotational devices.

Reposable instrument company Microline Surgical, Inc.,has received FDA 510(k) clearance for its MIS Flexible Ligating Shears, enabling surgeons to effectively cut and seal soft tissue. The flexible nature of the device promises new ways to utilize advanced energy across a wide range of transluminal and other advanced modes of surgical access.

Abbott has announced that the TECNIS® Toric 1-Piece intraocular lens has received U.S. FDA approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism.

Patient monitoring device company CAS Medical Systems, Inc., has received U.S. FDA 510(k) clearance for its next-generation FORE-SIGHT ELITE(TM) Absolute Tissue Oximeter, which it claims is more accurate than its predecessor.

MIS spinal implant company Medical Designs, LLC, has announced the launch of its recently FDA cleared SAMBA™ Screw System, indicated for sacroiliac joint fixation. The company aims to distribute its device through a network of independent reps and distributors.

A solid set of clinical data underpins FDAs decision to extend Endologix’s FDA approval to include so-called percutaneous endovascular repair (PEVAR) of triple AAAs. Seems the procedure is quicker, safer, less painful and requires fewer transfusions than EVAR.

CryoLife, Inc. has received U.S. FDA 510(k) clearance for its next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis.

Aptus Endosystems has gained CE mark approval for the thoracic version of its Heli-FX™ endovascular aneurysm repair graft. The the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor™ technology to the treatment of thoracic aortic aneurysms.

Drug delivery device company Carticept Medical, Inc., has received FDA 510(k) clearance to market its enhanced Navigator® Delivery System (DS). Navigator DS is the first and only FDA-cleared, computer-controlled injection system intended to increase the efficiency, comfort, safety and accuracy of musculoskeletal injections.

Critical care device company Teleflex Inc, has announced that its Anesthesia and Respiratory business unit has received FDA 510(k) clearance for its ISO-Gard® Mask with ClearAir™ Technology. The company says this novel product helps to reduce clinician exposure to hazardous waste anesthetic gases exhaled in “recovery”.

Boston Scientific Corporation has received U.S. FDA approval for its Precision Spectra Spinal Cord Stimulator System. The company is now beginning a limited launch of what it says is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts.

It would be easier to list the indications for which Biolase’s soft tissue laser has not been cleared, given that the 80 inclusions cover all aspects of surgical excision. Undeniably smart to take a dental laser and make it work in surgery, the company is now seeking commercialisation partners across other disciplines.

With a new FDA clearance, blood centers in the United States can now collect platelets on the Trima Accel system in 65 percent less plasma volume and store platelets in Isoplate for up to five days.

The CE mark approval of St.Jude’s deep brain stimulation devices represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary and secondary dystonia.