Boston Scientific Wins FDA Approval of Mini ICDs

Chris Newmarker

April 16, 2014

2 Min Read
Boston Scientific Wins FDA Approval of Mini ICDs

In but another sign of miniaturization in the cardiovascular space, Boston Scientific Corp. has announced FDA approval of defibrillators that it says are 20% smaller by volume and 24% thinner than competitive devices.

The FDA approval involved the Dynagen Mini and Inogen Mini ICDs from Boston Scientific. "The tiny size of the Mini ICD provides a real benefit to some patients, in particular those with a smaller frame," said Hans-Joachim Trappe, MD, of the University Marien Hospital Herne, Hospital of Ruhr-University, Bochum, Germany.Other next generation devices receiving approvals included the Dyangen X4 and Inogen X4 CRT-Ds, which Boston Scientific says offer 70% more pacing options to address high capture thresholds and phrenic nerve stimulation effectively, along with the largest battery capacity in the industry."Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients," said Joe Fitzgerald, executive vice president and president for the Rhythm Management division of Boston Scientific.The latest round of cardiac device approvals are but another sign of Boston Scientifics product pipeline finally paying off, helping the Natick, MA-based device giant turn around its fortunes.On February 5, Boston Scientific announced the U.S. launch of its OffRoad Re-Entry Catheter System, an important addition to the company's arsenal of tools to treat chronic total occlusions (CTOs). Boston Scientific CEO Michael Mahoney has repeated that the medical device giant remains enthusiastic about renal denervation as a treatment for high blood pressure--even after Medtronic and Covidien have decided to pull back from the space.The company's stock still isn't trading around $40 per share as it was about 10 years ago. But at more than $13 per share, it is up 11% for the year--making it one of the best performing medical device companies so far in 2014.

Besides the tinier ICDs, Boston Scientific has also been racing with Medtronic and St. Jude Medical to commercialize pill-sized pacemakers that could be implanted inside the heart in minimally invasive catheter procedures. Such devices would forgo the need for leads, which have long been the Achilles' heel of pacemaker devices.Miniature electronics and catheter procedures appear to have reached a point together where the old method of running wires to the heart could become medical history. And the devices are inserted inside the heart in a minimally invasive procedure, using a catheter.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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