A new study, entitled “TandemHeart to Reduce Infarct Size” (TRIS) will determine effect of ventricular unloading on myocardial salvage after acute myocardial infarction.
Techniques
Ascendx Spine™ Vertebral Compression Fracture System FDA 510(k) Cleared
Previously Ascendx Spine only had FDA clearance for its vertebral body excision device. Now it’s all systems go for commercialisation, as the rest of the system gets the nod.
1,000th European Implantation Of XPED Expandable Pedicle Screw
Expanding Orthopedics Inc. has passed the 1,000th XPED Expanding Pedicle Screw™ milestone at the prestigious and historical Rizzoli Institute in Bologna, Italy. The device, is a uniquely expandable pedicle screw designed to offer enhanced anchoring in compromised bone.
One Year Symplicity™ HTN-2 Trial Results Show Sustained BP Reduction
Published data demonstrate the Symplicity™ renal denervation system provides blood pressure reduction in patients with treatment-resistant hypertension sustained to 12 months
No More “Fat Hacking” As FDA Clears HydraSolve™ Lipoplasty System
A new liposuction cannula that avoids the traumatic sawing action employed during fact removal seems like a good idea. Now it’s gained FDA clearance.
iFuse® Reaches 5,000 Patient Landmark
MIS spine company SI-BONE, Inc. has seen the first peer-reviewed publication of clinical study results using its iFuse minimally invasive sacroiliac joint fusion device. At the same time the company has announced that it has reached the 5000 patient landmark.
CE Mark For BioVentrix Revivent® Myocardial Anchoring System
BioVentrix has received CE marking for its clever Revivent™ Myocardial Anchoring System, which makes possible Less Invasive Ventricular Enhancement™ (LIVE™), a procedure that restores the left ventricle from damage done by a heart attack to what the company calls a “more optimal” volume and conical shape.
First Transapical Implant of St.Jude’s Portico TAVI Offering
St. Jude Medical, Inc. has announced the first patient implant of its 23 mm Portico™ Transcatheter Aortic Heart Valve using the Transapical Delivery System.
CE Mark For Full Size Range of CardioKinetix Parachute™ Ventricular Partitioning Devices
CardioKinetix’s Parachute ventricular partitioning device has had its CE mark extended to include a full range of sizes, opening up percutaneous ventricular restoration therapy to a wider range of patient anatomies.
Stentys Trumpets IDE For Study To Demo Benefit Of Stent That Adapts To Vessel Dynamics
The theory is based on sound principles. Insert a coronary stent that is able to expand to adapt to changing vessel size and it will be more effective as the vessel dilates and clot dissolves. Now FDA’s approval of an IDE study will allow Stentys to back its claims.
BioKnee May Delay Or Avoids Knee Replacement
San Francisco sportsmed surgeon Kevin Stone’s eponymous Stone Clinic has formally introduced BioKnee: A natural knee cartilage reconstruction solution clinically-proven to delay the effects of arthritis for up to 12 years.
FDA Clears Novel Inguinal Hernia System Which Avoids Mesh Fixation
Insightra Medical has announced that its new Freedom inguinal hernia system has been cleared by the FDA. The device aims to address post-op chronic pain associated with traditional meshes by avoiding rigid fixation.
Implanted Tibial Nerve Stimulation For Overactive Bladder: Long-Term Study Promising
Voiding dysfunction device company Uroplasty Inc. tells us that positive results from a long-term clinical pilot study using an implantable tibial nerve stimulation device will be presented at the Annual Meeting of the International Continence Society.
FDA Clears Spinal Company Baxano’s iO-Tome™ Device For Precise Facet Joint Removal
Spinal device company Baxano sees its minimally invasive spinal fusion technology platform expand with the FDA’s clearance of its iO-Tome™ instrument for precise facet joint removal.
MRI Interventions And Brainlab Launch European Commercialisation Effort With First ClearPoint Case In Europe
ClearPoint Case Performed in Grenoble, France, the Birthplace of Deep Brain Stimulation Therapy
Heartwarming Development From Omaha Cardiac Surgeon
Congenital heart surgeon James Hammel, M.D., on Thursday presented a video demonstration of a novel infant cardiac surgical technique at the joint meeting of the Congenital Heart Surgeons’ Society and the European Congenital Heart Surgeons Association in Chicago. The technique allows many complex heart defect repairs, including the Norwood operation for hypoplastic left heart syndrome, to be performed more quickly and safely.