St. Jude and Boston Scientific get new CRT D devices approve

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efpat
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St. Jude and Boston Scientific get new CRT D devices approve

Post by efpat » December 2nd, 2011, 10:40 pm

Silver Spring, MD - The Food and Drug Administration has approved four new cardiac resynchronization therapy defibrillators (CRT-Ds): Unify Quadra (St Jude Medical, St Paul, MN) and Incepta, Endergen, and Punctua (Boston Scientific, Natick, MA), according to the companies [1,2].

According to St Jude, the Unify Quadra is the first quadripolar pacing system, which allows physicians to optimize resynchronization pacing without surgically repositioning the leads. The company plans to immediately begin marketing the device with its Quartet left ventricular pacing lead.

Boston Scientific is launching both CRT-D and regular implantable cardioverter defibrillator (ICD) versions of the Incepta, Endergen, and Punctua devices. According to the company, the new systems offer longer battery life and the 4-Site DF4 universal connector, which is easier for the implanting physician to connect to leads and allows the devices to be smaller than earlier CRT and ICD models.

Boston Scientific also simultaneously announced a new device warranty program that will cover its ICD and CRT-D devices in the US and many other countries for up to 10 years, depending on the model. Some of these devices were previously covered for only five years. The company says the extension is a response to data showing that most patients with these devices have them for at least seven years and that the company's latest batteries can last at least 10 years [3].

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Evan

Cardiomyopathy, LBBB, St. Jude Promote Plus CRT-D Installed Nov 9, 2009, QRS Duration - 180, EF - 25-30, EF NOW IS 50+!!!!!!

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Ozchrissy
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Re: St. Jude and Boston Scientific get new CRT D devices approve

Post by Ozchrissy » December 3rd, 2011, 12:18 am

Thanks for this, with my device and everything coming out, my cardiologist did say last Thursday that I will get the new device that is smaller when they get around to putting it back in. He also said they may evaluate whether I need the ICD, and just put in a CRT without the defibrillator. I guess by the time they are finished with me after all they will be going to do, they will have enough knowledge to really know what to put in. It do want to stick with Boston Scientific though.
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

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