Blog Coverage St. Jude Medical Announces FDA Approval and U.S. Launch of the First Device to Reduce Stroke Risk

The Company’s ILUMIEN III Clinical Trial Demonstrate Important Findings with Advanced Intravascular Imaging Technology

LONDON, UK / ACCESSWIRE / October 31, 2016 / Active Wall St. blog coverage looks at the headline from St. Jude Medical Inc. (NYSE: STJ). The company announced on October 28th, 2016, that the U.S. Food and Drug Administration (“FDA”) provided approval and launch of St. Jude Medical Inc’s AMPLATZER™ PFO Occluder to help reduce the risk of recurrent ischemic strokes in patients diagnosed with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

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What is PFO?

With the approval of the AMPLATZER PFO Occluder, patients in the U.S. with a PFO, who have suffered an ischemic stroke – a stroke resulting from blockages in the blood supply to the brain – will now have access to a closure device proven to reduce their risk of recurrent stroke rather than relying on medical management alone.

When a person suffers an ischemic stroke with no initial attributable cause, physicians will run tests to assess any underlying risk factors. These tests will include a test to determine if the patient has a PFO. Researchers long suspected a correlation between the presence of a PFO and the risk of a patient suffering an ischemic stroke; nearly half of all people who suffer a cryptogenic stroke also have a PFO. A PFO can potentially allow dangerous clots to pass from the right side of the heart to the left, travel up to the brain and cause a stroke. The AMPLATZER PFO Occluder is the only device approved in the US for PFO closure and has been shown to lower the risk of stroke by sealing the unwanted hole between the left and right chambers of the heart.

The Data Points

Data from the RESPECT trial, an eight-year clinical study of nearly one thousand patients diagnosed with both PFO and cryptogenic stroke, demonstrated PFO closure provides a clinically meaningful patient benefit over medical management alone, and that PFO closure with the AMPLATZER PFO Occluder reduced the risk of recurrent stroke by over half compared to standard medical treatment.

Long Process

In May 2016, an FDA advisory panel met to discuss the benefits and risks of the AMPLATZER PFO Occluder for treatment of recurrent stroke in patients with a PFO. The panelists concluded that PFO closure is an important medical therapy and offers clinically meaningful benefits for patients with a PFO who are at risk for recurrent stroke. The panel voted in favor of the device’s safety, effectiveness, and that the benefits of PFO closure with the AMPLATZER PFO Occluder outweigh the risks.

Mark D. Carlson, M.D., chief medical officer at St. Jude Medical stated:

“The approval of the AMPLATZER PFO Occluder is an important step for patients living in fear of recurrent stroke as a result of a PFO, and offers physicians more options to help their patients make decisions that best fit their lives.”

On October 30th, 2016, St. Jude Medical announced the ILUMIEN III trial met its primary endpoint demonstrating percutaneous coronary intervention (PCI) guided by optical coherence tomography (OCT) to be superior to angiography in stent expansion and procedural success and non-inferior to intravascular ultrasound (IVUS) guided-PCI in post-procedure minimal stent area (MSA).

The study enrolled 450 patients at 29 sites in eight countries. The company stated that the study was the first multicenter, prospective, randomized, controlled study to date comparing OCT-guided, IVUS-guided and angiography-guided PCI outcomes. The results confirmed that OCT-guided PCI Results are comparable MSA and stent expansion as IVUS-guided PCI. The use of OCT-guided PCI results in significantly greater stent expansion than angiography-guided PCI, with greater rates of procedural success; and that the OCT-guided PCI is superior to IVUS-guided PCI at detecting predictors of major adverse events (major stent malapposition and dissection).

In the ILUMIEN III study, physicians employed the St. Jude Medical™ OPTIS™ Integrated and ILUMIEN™ OPTIS™ PCI optimization systems, along with the Dragonfly™ imaging catheters designed for high-resolution imaging, to assess vessel and lesion characteristics, size stents, and optimize stent placement in patients randomized to OCT-guided stent implantation.

Next year, St. Jude Medical plans to expand research that demonstrates the long-term value of OCT further.

Stock Performance

St. Jude Medical’s share price finished yesterday’s trading session at $77.97, sliding 1.32%. A total volume of 5.67 million shares exchanged hands, which was higher than the 3 months average volume of 3.22 million shares. The stock has advanced 3.01% and 24.91% in the last six months and past twelve months, respectively. Furthermore, since the start of the year, shares of the company have surged 27.97%. The stock is trading at a PE ratio of 34.15 and has a dividend yield of 1.59%.

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