Cardio

CircuLite®, Inc. has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of its SYNERGY® IC Circulatory Support System, the first mechanical support system that does not require major surgery.

St.Jude’s says its new EnligHTN system offers simultaneous ablations with an intuitive touch screen generator, potentially enabling faster procedure times for the treatment of hypertension. A new study aims to back the claims.

St.Jude Medical Inc has issued a press release, telling us that Population Health Research Institute analysis continues to demonstrate strong safety and reliability of Optim-insulated leads. The data was presented at Heart Rhythm 2013 last week.

Sorin’s next-generation implantable defibrillators can now be monitored remotely using the company’s Smartview technology which has now gained FDA approval.

Stent company Biosensors International has entered into an agreement to acquire the assets of nuclear imaging company Spectrum Dynamics, a leader in advanced functional assessment technologies, including those used to evaluate patients for cardiac interventions. The move signals Biosensors developing an integrated approach to cardiac patient care.

A low-risk patient cohort has now seen enrollment completed in the PROACT study. When data is complete this study should establish whether reduction in anticoagulant drug therapy is feasible in this patient group, due to the design and material of the On-X valve. The announcement was made at last week’s American Association for Thoracic Surgery annual meeting.

Revenue for the quarter to end March increased by 33% over prior year, reflecting the impact of several new marketing initiatives leveraging positive validation from the MASTER I trial of the Company’s MGuard™ Embolic Protection Stent (EPS™).

St. Jude Medical, Inc. has announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

A first-in-human clinical trial using Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter for the treatment of type 1 atrial flutter has been completed in Australia.

Two new devices from the Medtronic ICD/CRT-D stable have gained FDA’s approval. These are the Viva®portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).

A second of the companies heading down the FDA’s new Early Feasibility Pilot Study route is Texan outfit BiO2 with its clever anti-embolic Angel Catheter. Strikingly, as the study gets the FDA’s nod to commence, the device is already on the market in Europe.

St.Jude’s MultiPoint Pacing study is designed to show improved effectiveness for patients when pacing multiple locations of the heart. Enrollment has begun in the 50 U.S. centers expected to recruit 500 patients.

Balloon Aortic Valvuloplasty looks like it’s been getting some serious design input as InterValve comes up with a figure eight shaped balloon for optimal rapid dilation. Now the device has added to its CE mark with a US FDA 510(k) clearance to market.

St. Jude Medical, Inc. has announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P). The device brings quadripolar lead technology to the pacemaker market for the first time.

CircuLite®, Inc. has announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY® Circulatory Support System. The results show clinically meaningful and sustained hemodynamic improvements, with a relatively low rate of adverse events when compared with larger support devices.

A newly published study suggests that CABG surgery results in improved survival at five years compared with a matched population of PCI patients, although the gap is narrowed where concomitant diseases exist.