Impulse Dynamics NV
Latest From Impulse Dynamics NV
A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.
FDA has set a panel meeting date in December that will include discussion of trial designs and potential indications for devices being developed to treat hypertension. Also, the advisory panel will look at an implantable device seeking approval for use in heart-failure patients.
The FIX-HF-5C trial, a subgroup study derived from the FIX-HF-5 pivotal trial, shows that the Impulse Dynamics Optimizer cardiac contractility modulation device significantly improved exercise tolerance and quality of life in certain heart-failure patients. Results of the trial were presented at the Heart Rhythm Society conference in Boston. Impulse Dynamics expects to file the final PMA module for US FDA for Optimizer in June.
Device and diagnostics fundraising slumped in Q2, but there was a substantial uptick in M&A activity. Device financings totaled just slightly over half of the previous quarter, while acquisitions grew almost six-fold, thanks primarily to Becton Dickinson's $23.5 billion play for CR Bard. Financing in diagnostics slid to $1.03 billion, less than half of Q1, whereas the $1.7 billion in M&As (most of that from PerkinElmer's $1.3 billion buy of EuroImmun) was more than double Q1's aggregate.
- Implantable Devices
- Therapeutic Areas
- Western Europe
- Parent & Subsidiaries
- Impulse Dynamics NV
- Senior Management
Simos Kedikoglou, MD, CEO
Andrew Coll, CFO
Daniel Burkhoff, MD, PhD, CMO
Mateusz Zelewski, MD, PhD, VP, Intl. Sales
- Contact Info
Impulse Dynamics NV
Phone: (599) 711 220456-0
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