Clinical Studies/Trials

In a strikingly heartwarming example of humanity charities already exist to coordinate the distribution of usable, explanted pacemakers from deceased Americans to less fortunate people in the developing world. A new study suggests this is a safe and viable practice, although the manufacturers disagree, citing concerns over reprocessing practices.

Medtronic, Inc. has announced findings from a health-economic analysis published online before print in The Journal of the American College of Cardiology that suggest the company’s Symplicity™ renal denervation system is a cost-effective treatment strategy for patients with treatment-resistant hypertension.

Research presented at last week’s ESC suggests Heartlight may deliver more durable PV isolation vs Cryoballoon ablation.

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.

Interventional Pulmonology company Pulmonx, has announced that the U.S. FDA has approved its request for an Investigational Device Exemption (IDE) to commence a multi-centre pivotal clinical trial which the company hopes will support a subsequent premarket approval application (PMA) for the Zephyr® Endobronchial Valve (EBV).

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.

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.

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.

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.

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.

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.

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.

Renal Denervation is probably the biggest buzzphrase in new therapies right now, given the size of the problem it purports to address. Medtronic has seen more promising data published at ESC, suggesting patients treated with its Symplicity™ system benefit from sustained and meaningful BP reduction at 18 months

GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

Cook Medical’s Zilver® PTX paclitaxel-eluting peripheral vascular stent demonstrated 83.0 percent freedom from Target Lesion Revascularisation at 36 months in the PTX group, compared to 70.2 percent for patients treated with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study.

Germans medical device company Cerbomed GmbH has received CE mark clearance for the application of transcutaneous Vagus Nerve Stimulation (t-VNS) in pain relief therapy.