Biotronik now boasts one of the longest drug-eluting stents on the market across all diameters with the market release of new 35 and 40 mm versions of Orsiro, the industry’s first hybrid Drug Eluting Stent (DES) featuring a bioabsorbable polymer.
Cardio
Significant Reduction in All-cause Mortality with BIOTRONIK Home Monitoring® of ICD and CRT-D patients
Biotronik, has used the annual European Society of Cardiology event at which to announce what it calls ground-breaking results from its IN-TIME study. This is the first randomized, controlled trial worldwide, and demonstrates a significant reduction in all-cause mortality in heart failure patients with implant-based remote monitoring.
First U.S. Patient Treated with U.K. Company Lombard Medical’s Aorfix™ Flexible Aortic Stent Graft
Lombard Medical Technologies, plc has seen a first U.S. patient treated with its Aorfix™ endovascular stent graft for repair of an abdominal aortic aneurysm. Aorfix is the only endovascular stent graft with approved labeling for use in more challenging cases with neck angulations greater than 60 degrees.
Dallen Medical Tells us FDA has Cleared its Coated Compressyn™ Band, But Not Much About It
Dallen Medical has received FDA 510(k) clearance for a polymer-coated version of its Compressyn™ Band for sternal closure. This clearance follows earlier clearances for its non-coated Compressyn Band and the company’s Compressyn Staple for foot, ankle & hand fixation and repair.
Medtronic/Edwards TAVI Duel Plays Out as German Injunction Shuts Door on CoreValve
Edwards Lifesciences Corporation announced that the injunction against sales of Medtronic’s transcatheter heart valves in Germany had gone into effect. In a magnanimous gesture, Edwards is allowing for exceptions where its own Sapien valve is not indicated, but Medtronic’s CoreValve is.
Single-Site Cannulation ECMO for SynCardia Total Artificial Heart Patient
SynCardia Systems, Inc. has announced that doctors have published the first case report detailing use of single-site cannulation with extracorporeal membrane oxygenation to successfully treat adult respiratory distress syndrome in a patient implanted with the SynCardia temporary Total Artificial Heart.
Abbott Completes Acquisition of IDEV Technologies
Abbott has expanded its global peripheral technology portfolio with the acquisition of IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional radiologists, vascular surgeons and interventional cardiologists.
FDA Nod for Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter and Zurpaz™ 8.5F Steerable Sheath
Boston Scientific Corporation continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath. The company says these products join its growing portfolio of next generation EP tools designed to redefine ablation technology.
St.Jude’s Endosense Acquisition Makes Sense
St. Jude Medical adds ablation catheter with contact-force measurement to its industry-leading atrial fibrillation portfolio and accelerates U.S. timeline for AF ablation indication.
St.Jude’s Newly Approved Ablation Navigation System Reduces Radiation Exposure
St. Jude Medical, Inc., has seen its MediGuide Enabled™ Ablation Catheters gain U.S. FDA approval. The company is touting reduction in radiation exposure for patients, MediGuide using a previously recorded fluoroscopic map of the target tissue.
Remarkable Tale of French Patient After Two Years with SynCardia Total Artificial Heart
Despite being described as a short-term bridge to transplantation, a French patient now has two years of assistance under his belt with the SynCardia temporary total artificial heart.
First Patient Suggests Real Promise for Revivent™ Heart Failure Treatment System
BioVentrix’s Revivent less invasive treatment reshapes the left ventricle of patient too fragile to undergo conventional surgical reconstruction. Now it’s been used successfully for the first time in man.
Labelling Correction Prompts “Recall” for Cordis Optease Retrievable Inferior Vena Cava Filter
Cordis and the FDA have notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize likelihood of implanting the company’s Optease Vena Cava filter backwards.
OrbusNeich COMBO Dual Therapy Stent™: Routine Practice Registry Starts Enrolling
Patient enrollment has been initiated in a post-market registry for the COMBO Dual Therapy Stent to evaluate its long-term safety and performance in routine clinical practice.
FDA Grants Edwards IDE for US Trial of SAPIEN 3 Transcatheter Valve
Transcatheter valve pioneer, Edwards Lifesciences Corporation has received conditional Investigational Device Exemption approval from the U.S. FDA to initiate a clinical trial of its new Edwards SAPIEN 3 transcatheter aortic heart valve and accessories.
Turkey’s 1st Pediatric Patient to Receive the SynCardia Total Artificial Heart Celebrates 18th Birthday
Turning 18 years old is an important milestone in any young man’s life, but even more so for Yusuf Enec (photo). This time last year, Yusuf wasn’t sure he’d live to see it. However, thanks to the SynCardia temporary Total Artificial Heart, today he has the chance to celebrate.