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New Indication for Medtronic's Bone Cement Gets 510(K) Nod

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Medtronic plc (MDT - Free Report) continues to hit headlines with its steady strategic developments. Recently, the company caught investors’ attention on the receipt of expanded 510(k) clearances for the company’s Kyphon HV-R Bone Cement for fixation of pathological fractures of the sacral vertebral body. This new breakthrough is expected to expand the company’s Interventional Pain Therapies business within the broader Restorative Therapies Group (RTG).

Per Medtronic, the fixation will be done using sacral vertebroplasty or sacroplasty. With this expanded indication, the company will be able to broaden its commitment toward the treatment of pathological fractures of the vertebral body caused by osteoporosis, cancer or benign lesions. The company claims this advancement to offer clinicians more options in curing patients with sacral insufficiency fractures (SIF).

Notably, SIFs are a common cause for debilitating back pain. Per American Journal of Neuroradiology (ANJR), SIFs are a frequent yet often unsuspected reason behind low back pain in the elderly patients. Very recently, sacroplasty emerged as an alternative therapy for the treatment of SIFs. According to ANJR, prospective studies and case reports suggest that it is a safe and effective remedy.

Per Medtronic, SIFs show the symptoms of lumbar spine pathology. Going by studies, more than two-thirds of SIF patients fail to associate their pain with a traumatic event. Evidently, they are often being prescribed with conservative treatment options including physical therapy and prolonged bed rest. These are highly expensive choices inducing loss of productivity within the healthcare system. Also, patients put to bed rest are at a rising risk of pulmonary embolism and DVT as well as further muscle atrophy and bone loss.

Meanwhile, SIF patients treated with sacroplasty experience immediate pain relief, allowing them to resume daily activity and/or physical therapy without suffering pain and physical limitations. More encouragingly, the procedure of sacroplasty with HV-R cement is pretty simple owing to its minimally-invasive procedure and the therapy can be performed in an outpatient setting.

Demographic Change and SIF

Going by a report published in National Center for Biotechnology Information (NCBI), epidemiologic changes in first and second world countries will inevitably lead to a constant increase of the grey populace. Also, per the United Nations data, global aging population (aged 60 years or above) came in at 962 million in 2017, more than double the figure registered in 1980, when the strength of senior citizens was 382 million worldwide. The number is again expected to grow twice as dense by 2050 when it is projected to reach nearly 2.1 billion.

Therefore, detection of SIF among elderly adults, is markedly gaining prominence with huge prospects for its treatment market. Hence, we believe Medtronic’s latest innovation in this space to be well-timed and strategic.

Price Performance


Medtronic has outperformed the industry in three months’ time. The stock has gained 9.9% compared with the industry's rise of 7.4%.

Key Picks

Medtronic currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are Genomic Health (GHDX - Free Report) , Abiomed (ABMD - Free Report) and Stryker Corp. (SYK - Free Report) .

Genomic Health has an expected earnings growth rate of 187.5% for the second quarter of 2018. The stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Abiomed has a projected long-term earnings growth rate of 27% and a Zacks Rank of 1.

Stryker has a projected long-term earnings growth rate of 9.7%. The stock carries a Zacks Rank #2 (Buy).

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