6 Products St. Jude Medical is Banking On in 2014

Posted in Medical Device Business by Arundhati Parmar on April 16, 2014

St. Jude Medical wants to deliver a higher growth rate in the U.S. Executives believe these six products will help achieve that.  

St. Jude Medical reported a solid first quarter Wednesday beating analyst estimates of earnings per share by a penny. The Minnesota medical device maker had revenue of $1.36 billion in the quarter ended March 29, up 2% from $1.34 billion it garnered in the same quarter a year ago. Profits climbed to $249 million, or 96 cents per share from $223 million, or 94 cents in the quarter.

But St. Jude Medical wants to do even better in the rest of the year domestically, which includes improving its sales growth rate. For that, it is banking on six products. They are:

CardioMEMS - CardioMEMS is a closely-watched startup that St. Jude is acquiring before mid 2014, which many believe has developed what could be a game-changing technology to manage congestive heart failure patients who rack up huge bills for repeated hospitalizations. Hospitals today are being penalized by Medicare if these patients are readmitted in the hospital within 30 days of discharge.

The CardioMEMS device is an implantable sensor that is able to monitor intracardiac pressure and alert physicians of any change, who can respond appropriately, thereby preventing hospitalization of these patients. The promising solution is based on a wireless sensing and communication technology for the human body. After initially rejecting the device’s premarket approval application, analysts believe that FDA will now approve it. The approval is expected to come by mid year.

Here is what Daniel Starks, CEO of St. Jude Medical described the product in an earnings conference call Wednesday:

As we have communicated previously, this product launch will be supported by clinical data from the landmark CHAMPION trial that shows Class III heart failure patients whose medical therapy is guided by a CardioMEMSsystemenjoy a higher quality of life and are hospitalized less often. Reimbursement already is in place in the United States for the implant procedure.Patient monitoring already can be facilitated by our remote monitoring system

Assurity, Endurity and Allure Quadra CRT-P - FDA recently approved these three cardiac rhythm management products, St. Jude announced in March 24. The Allure Quadra CRT-P brings quadripolar pacing technology for the first time to the U.S. and allows allows physicians more pacing configurations within the heart that are not possible through traditional bipolar systems.

Starks remarked that revenue from low-voltage devices in the U.S., that include the above product actually fell 9% in the quarter on a constant currency basis, which can partly be attributed to the fact that these same devices were launched internationally in the first quarter of 2013 making a difficult comparison to the first quarter of this year.

“We expect the difference in international and U.S. sales growth rates to narrow as we launch products in the United States that already have been launched in key international markets in 2013,” Starks said.

TactiCath Force-Sensing Ablation Catheters - This product, like CardioMEMS, comes from an acquisition. In 2013, St. Jude Medical bought Endosense, based in Geneva, which pioneered the force-sensing TactiCath irrigated ablation catheter that can tell physicians in real time how much force they are applying to a heart wall during a cardiac ablation procedure to repair cardiac arrhythmias. That knowledge is key to understanding the efficacy of the ablation being done.

Too much force can cause tissue injury and procedure complications, while too little force can lead to incomplete lesion formation, which essentially means that atrial fibrillation can recur down the road requiring a repeat ablative procedure.

Starks said the company expects FDA approval for this line of products in the second half of the year.

Protege Line of Spinal Cord Stimulation Devices - St. Jude expects to launch these SCS devices in the latter half of the year following FDA approval earlier in April. Starks noted how Protege is the “world's smallest and longest-lasting rechargeable device to treat chronic pain.”

It is also the first neurostimulator that can get approved SCS technology upgrades via regular software updates so passe in the the tech world.

[Photo Credit: user draco77]

-- By Arundhati Parmar, Senior Editor, MD+DI


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