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Abbott's (ABT) Proclaim XR SCS Gets FDA Nod for New MRI Label

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Abbott Laboratories ABT recently received a new FDA approval with its Proclaim XR spinal cord stimulation system (SCS) for people with chronic pain. This time the regulatory body has approved an expanded magnetic resonance imaging (MRI) compatibility for the Proclaim XR platform with Octrode leads.

Per Abbott, with the expanded MRI labeling, patients who are implanted with Proclaim XR SCS device can benefit from higher quality images with faster MRI scan times.

This latest approval will augment Abbott’s Neuromodulation arm, which is having a hard time amid the COVID spell due to its elective nature of business.

Proclaim XR SCS

SCS is an implanted device that helps relieve chronic pain by sending low levels of electricity directly into the spinal cord.

Abbott’s Proclaim XR Recharge-Free SCS system allows patients to attain relief from chronic intractable pain of the trunk and limbs. By delivering low doses of stimulation, the system's battery can last up to 10 years without the burden of recharging.

The MRI Labeling

According to Abbott, MRI scanners use powerful magnets and radiofrequency energy to create detailed images of the inside of the body. However, it’s a matter of concern that how these magnets and radiofrequency energy could impact the placement of implantable devices, imposing restrictions on the use of MRIs when a patient has a particular device.

In such a scenario, it becomes necessary to find an imaging facility willing to modify the workflow and work within the MRI labeling limitations of the patient's implant.

Advantage of the Expanded MRI Labeling

The new MRI labeling by Abbott claims to lift MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan. The expanded labeling covers the majority of Proclaim XR patients, providing additional benefits to those patients and their health care providers.

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Abbott noted that with the new labeling, Octrode lead tips can be placed anywhere along the spine and still be considered MR Conditional (means a patient can undergo MRI scans within the approved outlined conditions). Radiofrequency energy no longer needs to be limited with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode.

This new labeling also reduces scan time to the permissible range. Patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes. In general, the FDA requires radiologists to pause MRIs for anywhere from 30 to 60 minutes between scan cycles for patients with implants.

Further, the label update will also benefit existing patients implanted with Proclaim XR SCS Systems with Octrode leads improving their access to MRI imaging.

Industry Prospects

Per a report by Market Data Forecast, the global SCS market was estimated at $1,871.6 million in 2018 and is expected to reach $2,827.4 million by the end of 2023, with a CAGR of 8.6%. The key factors driving the market are the growing elderly population and the speedy technological advancements made in SCS. Also, the promising health reimbursement policies currently available in the United States are encouraging.

Given the current market potential, this approval is well-timed.

Update on Neuromodulation

Despite the ongoing pandemic-induced difficulties within Abbott’s neuromodulation arm, the company is optimistic about a strong rebound in the near term, banking on successful trial runs and a strong pipeline of products. Apart from SCS, the company is looking forward to its newly-launched NeuroSphere, its advanced remote care platform. The company did a full market release at the end of June 2021 and since then it has been witnessing strong customer response. Per the company’s last update in October, it has done over 5,000 remote programming sessions.

Share Price Performance

The stock has outperformed its industry over the past year. It has risen 23.1% against the industry’s 5.5% fall.

Zacks Rank and Other Key Picks

Currently, Abbott carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the broader medical space that investors can consider are Apollo Endosurgery, Inc. APEN, Cerner Corporation CERN and Poseida Therapeutics, Inc. PSTX, each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Apollo Endosurgery has a long-term earnings growth rate of 7%. The company‘s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 25.6%, on average.

Apollo Endosurgery has outperformed its industry in the past year. APEN has gained 132.2% compared with the industry’s 12.6% growth.

Cerner has a long-term earnings growth rate of 13.3%. The company’s earnings surpassed estimates in three of the last four quarters and met estimates once. Cerner has a trailing four-quarter earnings surprise of 3.2%, on average.

Cerner has outperformed its industry in the past year. CERN has gained 19.5% against the industry’s 38.2% decline.

Poseida Therapeutics has a long-term earnings growth rate of 9.9%. The company’s earnings surpassed estimates in the trailing three quarters and missed in one, delivering an average surprise of 4.3%.

Poseida Therapeutics has underperformed its industry in the past year. PSTX has declined 32.4% compared with the industry’s 22% fall.


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