UK regulatory authority the MHRA is very keen to ensure that all pertinent information on the management of the potential for externalised ICD leads, reaches the appropriate medical professional, so has issued a follow up device alert with updated guidance.
Cardio
ESC Data Points To Reduced AF Ablation Redo’s With HeartLight® When Compared With Cryoballoon
Research presented at last week’s ESC suggests Heartlight may deliver more durable PV isolation vs Cryoballoon ablation.
CE Mark For World’s Smallest Surgically Implanted Blood Pump
US/German device company CircuLite®, Inc. has announced that it has received CE Marking approval for the Synergy® Circulatory Support System, claimed by the company to be the world’s smallest surgically implanted blood pump designed for long-term use in patients diagnosed with the condition.
First Patient In Biotronik’s Multicentre PARCADIA Study Into Risk-Stratification For ICD Interventions
The first patient has now been enrolled in the Biotronik-supported study which aims to identify risk factors that can help predict appropriateness of ICD interventions.
Renal Stent Study Shows Lower BP In Refractory Hypertension
It seems renal artery disease is a bigger predictor of one’s demise than coronary artery disease, so it’s perhaps reasurring to see a paper claiming that stenting of the renal arteries is an effective measure in reducing blood pressure over a sustained period.
The Value Of Medical Congresses: Discuss. This Week’s “View From The Med” Online Now
This week’s View From The Med is ready to read… unless you’re a tired ESC delegate wending your way home after another exhausting bash.
CoreValve®: High Risk Patient Study Enrollment Complete, FDA Says Yes To Start Intermediate Risk Patient Study
Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.
St. Jude “Restructures” 300 Jobs Away, And Reshuffles Execs In Future-Proofing Move
St.Jude has taken the radical decision to shoe-horn its previous four divisions into two. These will be called the Implantable Electronic Systems Division (IESD), which will encompass CRM and Neuromodulation, and the Cardiovascular and Ablation Technologies Division (CATD), which will encompass Atrial Fibrillation and Cardiovascular. 300 job cuts and a host of efficiency savings are anticipated.
Navigator™ System Turns CV Data Into Information, Says Study
In a survey of triallists, 100% of respondents said that Navigator™ enhanced patient care. All said they would continue to use the cardiovascular monitoring and clinical decision-making system if made available.
CE Mark For Elixir’s Biodegradable Polymer Coating/ Drug Elution Combo Stent
Elixir Medical claims to be the first company to now offer both durable and biodegradable polymer platforms for DES with the news that its absorbable polymer/drug eluting technology has been CE marked in the form of its DESyne BD Novolimus eluting stent system.
St.Jude’s Renal Denervation System Works Too!
Twenty eight point reduction of systolic blood pressure after one month remained stable at three months using EnligHTN renal denervation system according to ESC hotline session data.
Could TAVI Ever Be Primary Choice?
OK it’s all work supported by the main industry players, but a registry’s a registry and in Germany it appears that the body of evidence is growing that TAVI is a technique that is gaining ground for all the right reasons and could even usurp conventional surgery in years to come.
Boston’s WATCHMAN® LAA Closure Device Sees Its CE Mark Extended To Include AntiCoagulant-Limited Patients
Boston Scientific’s Watchman LAA closure device can now be used on patients not able to be given anticoagulant therapy. Also, newly revised European Society of Cardiology guidelines include LAA closure devices.
Mitraclip Registry Suggests Device Uptake For Older, Sicker Patients
Registry data presented at ESC suggests MitraClip use is gathering pace, at least for the oldest and sickest patients for whom it is providing an alternative to surgical valve repair.
Results Of IABP Study In Cardiogenic Shock Patients Only Hint At Benefit
Maquet Cardiovascular has issued a press release pointing us to the publication at ESC of clinical data which says its intra-aortic counterpulsating balloon shows observable 30 day reduction in mortality. The study size dictated that a 12% reduction was required in order to demonstrate significance, a target which was not reached.
Journos From Medscape And theheart.org Shown The Door At ESC For Embargo Break
It’s all kicking off at ESC as two journalists get the heave-ho for what looks like an accidental embargo break. Blimey.