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$STJ St. Jude Medical today announced FDA approval of MR-conditional labeling for STJ’s Penta 5-column paddle lead for SCS therapy to manage chronic pain. The Penta lead, which will be available for use with STJ’s Protege MRI system in US, is the only 5-column paddle lead on market that will allow patients to safely undergo head & extremity MRI.
$STJ said its BoD declared a 4Q16 dividend of $0.31 per common share. This brings the total dividend declared for the year to $1.24 per share. The dividend is payable January 31, 2017, to shareholders of record on January 13, 2017, provided the pending merger with $ABT is not effective before the close of business on the record date.
$STJ said the U.S. Food and Drug Administration (FDA) approval and launch of the 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.
$STJ said that it is on track to close the transaction with $ABT by the end of 2016. The company recently announced that it will sell its Angio-Seal and Femoseal vascular closure devices, which are also expected to close by the end of 2016. Until that time, $STJ will continue to manufacture and sell these devices.
$STJ received an approval from FDA for its BurstDR therapy for chronic pain. The company expects additional product approvals during 4Q16 to drive further sales growth in 2017. In Europe, $STJ expects to receive approval for its next-generation Confirm implantable cardiac monitor technology before the end of 2016.
In 3Q16, $STJ posted Atrial Fibrillation product sales of $316MM, up 14% from 3Q15. Heart Failure product sales were $351MM, up 46% and sales of neuromodulation products were $141MM, up 17% from last year. Total cardiovascular sales were $313MM, up 8%. Total CRM sales were $378MM, down 7% from 3Q15.
Medical devices company $STJ reported a decline 3Q16 earnings hurt by after-tax charges related to amortization of intangible assets and acquisition-related costs. Net income fell to $212MM or $0.73 per share from $215MM or $0.75 per share last year. Net sales grew 12% to $1.5Bil. Adjusted EPS increased to $0.99 from $0.97.
$STJ will sell certain products to Terumo Corp for $1.12Bil, subject to the completion of $ABT's acquisition of $STJ and antitrust regulatory approvals. $ABT, $STJ & Terumo are bound by the terms of an exclusivity agreement. The divestiture will include $STJ's Angio-Seal & Femoseal vascular closure products, and $ABT's Vado Steerable Sheath.
$STJ announced the US clearance and launch of its PressureWire X Guidewire fractional flow reserve measurement system. This system aims to reduce vessel trauma in patients during percutaneous coronary intervention (PCI). A PCI procedure is designed to restore blood flow in patients with coronary artery disease, a common type of heart disease.
Medical device company $STJ announced the approval of BurstDR stimulation by the US Food and Drug Administration. BurstDR stimulation is a physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior outcomes for patients with chronic pain over traditional SCS therapy.
Medical devices company $STJ said its BoD declared a 3Q16 dividend of $0.31 per common share of the company's stock. This brings the total dividend declared for the year to $0.93 per share. The dividend is payable October 28, 2016, to shareholders of record on September 30, 2016.
$STJ said it expects to receive U.S. FDA approval for its MRI safe pacemakers and implantable cardioverter defibrillators in the second half of 2016 and in the first half of 2017. $STJ expects the approvals to boost its U.S. Cardiac Rhythm Management business which is currently pressured by product gaps.
RBC Capital Markets analyst Glenn Novarro asks $ABT what the upside surprises are within the $STJ portfolio over next 5 years. CEO Miles White says $ABT is optimistic about the uptick, penetration & introduction of products. But reimbursements or timing of an approval could slow down the company in delivering its products on time & on schedule.
JP Morgan analyst Michael Weinstein asks $ABT to provide an update on $STJ and $ALR transactions. CEO Miles White says that there has been no change in the $ALR transaction. $ALR has not filed a 10-K yet, and there are no new updates regarding that deal. With regards to $STJ, everything is on track & $ABT expects to close the deal before 2016-end.