Approval/Clearance

An emerging medical device manufacturing company (that we’d never come across until now), Advanced Cooling Therapy (ACT), has received CE marking for its first product, the Esophageal Cooling Device (ECD) to control patient temperature. The product is now available to medical professionals in Europe.

Ortho Development® Corporation has received FDA clearance for its Ovation Tribute™ Hip Stem. The Ovation Tribute is a femoral hip prosthesis that is intended for cementless use in total hip replacement and hemiarthroplasty procedures.

Medtronic has gained CE Mark approval for its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. The company says this is the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.

Abiomed has received CE Mark approval to market its Impella RP device in the European Union, providing a non surgical heart support option for patients with reduced right ventricular function.

Boston Scientific Corporation has received U.S. FDA clearance and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which means it is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.

Cardiovascular device specialist, Edwards Lifesciences Corporation has received CE Mark approval for its EDWARDS INTUITY Elite valve system. The company says its next-generation, rapid deployment system facilitates smaller incisions in surgical aortic valve replacement procedures

Clever little device this, a thing looking like a glorified cable-tie, but deliverable laparoscopically using a 5mm diameter instrument, all aimed at fixing hernia mesh in place securely and with minimal foreign body.

St. Jude Medical, Inc., is trumpeting the U.S. FDA approval of its Protégé™ IPG, the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades to be made via software updates.

Cardiovascular device company Biotronik has announced that the first patients across the United States have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs)

Extremity Medical, LLC has received U.S. FDA 510(k) clearance for the HammerFiX™ for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Mobius Imaging has gained CE Mark approval for its Airo Mobile Intraoperative CT System, distributed under an exclusive sales and service agreement with German company Brainlab.

CryoLife, Inc. has received approval of its Investigational Device Exemption (IDE) for PerClot from the U.S. FDA. This approval allows CryoLife to begin its pivotal clinical trial to gain approval to commercialize PerClot in the U.S.

Ablative Solutions, Inc., has received U.S. FDA 510(k) clearance for its Peregrine System™ Infusion Catheter. The system uses a unique, patent-pending technology to deliver diagnostic and therapeutic agents directly to the perivascular layer that surrounds blood vessels.

Italian Cardiovascular device specialist Sorin Group tells us its Perceval™ sutureless aortic valve has received CE mark approval for adult age indication allowing treatment of a wider spectrum of patients with aortic stenosis and/or steno-insufficiency.

Rotation Medical, Inc. tells us it has received U.S. FDA 510(k) clearance for its implantable collagen scaffold technology. The new technology is designed for use during arthroscopic and mini-open procedures to help support clinical management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Robot surgery device specialist Intuitive Surgical, Inc., has announced the U.S. FDA clearance and introduction of the da Vinci Xi Surgical System, which it says represents a technological leap forward in replacing large-incision abdominal surgeries (open surgery) with a minimally invasive approach.