Boston Scientific's Synergy

Boston Scientific's Synergy stent is made with thinner struts and a bioabsorbable polymer coating that dissolves about three months after implantation, with the intention of quicker healing.

Synergy gained CE Mark in October 2012 and has become a popular choice for with European physicians. On a recent earnings call, Boston Scientific executives noted that Synergy makes up 30% of company's drug-eluting stent sales in Europe.

Synergy was the subject of the EVOLVE II U.S. pivotal trial. U.S. patients won't have to wait long . . . the stent is...

July 27th, 2015
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St. Jude Medical's Portico

St. Jude Medical's Portico transcatheter aortic valve is a repositionable, retrievable implant that has had CE Mark since .

Portico received CE Mark for its 23 mm size in November 2012 and for its 25 mm size in December 2013. The valve is being studied in a U.S. pivotal trial for FDA approval.

In September 2014, both commercial and trial implants were halted to investigate what was thought to be unusual reduced mobility of the...

July 27th, 2015
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NeoChord's DS1000

NeoChord has developed the DS1000 for minimally-invasive mitral valve repair in patients suffering from severe mitral valve regurgitation.

Transapical transcatheter mitral valve repair with the DS1000 reduces the necessary incision from 3–10 inches to 2–3 inches and allows the procedure to be done off pump, according to information on the NeoChord Web site. This means the patient's heart continues beating during the procedure, as opposed to being stopped and put on cardio-pulmonary bypass.

The DS1000 received CE Mark in December 2012 but does not have FDA approval.

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July 27th, 2015
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Thoratec's HeartMate PHP

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Thoratec's HeartMate PHP is a heart pump intended for hemodynamic support in high-risk percutaneous coronary intervention (PCI) patients. HeartMate PHP received CE Mark in July 2015 but does not yet have FDA approval.

The SHIELD II U.S. pivotal trial is to be conducted in patients undergoing high-risk PCI to support an FDA approval. The randomized trial pits HeartMate PHP against Abiomed's Impella 2.5, which has FDA approval and is the only direct competitor.

Analysts expect HeartMate PHP could receive FDA approval in 2018. 

July 27th, 2015
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Endologix's Nellix

Endologix developed the Nellix endovascular aneurysm sealing system to give a minimally invasive option to patients who cannot receive conventional endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs). These patients may have challenging aortic anatomy that does not fit traditional EVAR devices. 

The Nellix system uses polymer-filled endobags to seal off the aortic aneurysm and prevent further aneurysm expansion or rupture.

Nellix received CE Mark in January 2013 and has been much buzzed about at vascular medical meetings ever since. Analysts expect Nellix to gain FDA approval...

July 27th, 2015
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Abbott's Absorb

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Abbott's Absorb Bioresorbable Vascular Scaffold (BVS) is a drug-eluting device that is used in angioplasty to open a narrowed coronary artery. The scaffold dissolves after about two years, so patients no longer have a foreign device in their arteries.

When it received CE Mark back in January 2011, Absorb was the first drug-eluting BVS to be approved. Since then, iterations on the platform have been approved—most recently, the Absorb GT1 with the GlideTrack catheter received CE Mark in May 2015. Abbott recently filed a U.S. submission for FDA approval of Absorb.

July 27th, 2015
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Medtronic's MiniMed 640G

Medtronic announced the launch of its MiniMed 640G system outside the United States in January 2015.

The system consists of a insulin pump, continuous glucose monitoring sensor, blood glucose meter, and software that automatically stops administration of insulin as blood glucose levels are predicted to fall too low, and restarts insulin once safer glucose levels are restored.

MiniMed 640G system is not yet available in the United States but the company plans to submit a PMA to FDA for the system later in 2015.

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July 27th, 2015
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Medtronic's Micra TPS

Medtronic's Micra Transcatheter Pacing System (TPS) is a leadless pacemaker that is implanted into the heart using a transcatheter procedure.

Micra TPS received CE Mark in April 2015 and is the smallest pacer in the world. It was not the first leadless pacer to be approved, however—that...

July 27th, 2015
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Yband

Ybrain,'s Yband headband uses nerve stimulation to combat the effects of neurological diseases such as Alzheimer’s, mild cognitive impairment, and major depressive disorder. The company says its wearable technology is "an evolutionary method to modulate cognitive function simpler and safer than surgery or medication."

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July 24th, 2015
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Buzzy

Invented by Dr. Amy Baxter after her son had a bad needle-stick experience, the Buzzy device uses vibration and cold to block pain without drugs. The device can be used to block pain from shots as well as help reduce general body aches and pains.
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July 24th, 2015
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