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Inspire Medical (INSP) Dips on FDA Recall of IPG Model 3028
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Inspire Medical Systems Inc. (INSP - Free Report) has issued a recall of its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a critical manufacturing defect. The FDA has classified this as the most serious type of recall, as the defect can lead to electrical leakage in the sensing circuit post-implantation. This leakage can cause system malfunctions, potentially resulting in severe health consequences, including inconsistent stimulation, painful shocks or even death. There may be an urgent need for revision surgery to replace the IPG.
Following the news, shares of INSP declined 3.3% during yesterday’s trading session to close at $131.44.
Significance of the Recall
The IPG is a crucial component of the Inspire Upper Airway Stimulation system, which is designed to maintain airway patency during sleep by delivering mild electrical stimulation to the hypoglossal nerve. The IPG works together with external programmers that allow the physician to set and adjust the therapy parameters and the patient to control the therapy's activation and intensity. Per Inspire Medical Systems, the recall of the Inspire IV Implantable Pulse Generator is of utmost importance due to the possible severe adverse health effects it can cause.
A defect in this device can lead to stimulation below normal therapeutic levels, early battery depletion, inconsistent or inappropriate stimulation and painful or shocking sensations. These issues necessarily prompt identification and correction to prevent serious health risks and ensure the safety and efficacy of the therapy.
In the first quarter of 2024, the company reported a 25% year-over-year increase in U.S. revenues, banking on increased market penetration of Inspire therapy. The recall of the Inspire IV IPG model 3028 might dampen the company’s future sales.
Industry Prospects
Per Verified Market Reports, the global implantable pulse generator market size was valued at $118.57 billion in 2023. It is anticipated to reach $188.76 billion in 2030 at a CAGR of 8.6%.
The market for implantable pulse generators is expanding significantly due to advances in medical technology and the rising incidence of neurological illnesses and chronic pain. In response to patient preferences for less intrusive treatments, smaller and more effective devices with improved battery life and wireless communication are being developed. The growing need for smart features and individualized therapy is also shaping implantable pulse generator developments.
Price Performance
Shares of Inspire Medical have declined 35.4% so far this year compared with the industry's 19.5% decline. The S&P 500 has witnessed a 17.5% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Inspire Medical carries a Zacks Rank #4 (Sell).
Some top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Universal Health Services (UHS - Free Report) and Ecolab Inc. (ECL - Free Report) .
DaVita, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 43.4% compared with the industry’s 15.2% rise in the past year.
Universal Health Services, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.80%. UHS’ earnings surpassed estimates in the trailing four quarters, with an average of 8.12%.
Universal Health Services has gained 21.3% against the industry’s 20.4% decline in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.3%.
Ecolab’s shares have rallied 31.3% against the industry’s 12.9% decline in the past year.
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Inspire Medical (INSP) Dips on FDA Recall of IPG Model 3028
Inspire Medical Systems Inc. (INSP - Free Report) has issued a recall of its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a critical manufacturing defect. The FDA has classified this as the most serious type of recall, as the defect can lead to electrical leakage in the sensing circuit post-implantation. This leakage can cause system malfunctions, potentially resulting in severe health consequences, including inconsistent stimulation, painful shocks or even death. There may be an urgent need for revision surgery to replace the IPG.
Following the news, shares of INSP declined 3.3% during yesterday’s trading session to close at $131.44.
Significance of the Recall
The IPG is a crucial component of the Inspire Upper Airway Stimulation system, which is designed to maintain airway patency during sleep by delivering mild electrical stimulation to the hypoglossal nerve. The IPG works together with external programmers that allow the physician to set and adjust the therapy parameters and the patient to control the therapy's activation and intensity. Per Inspire Medical Systems, the recall of the Inspire IV Implantable Pulse Generator is of utmost importance due to the possible severe adverse health effects it can cause.
A defect in this device can lead to stimulation below normal therapeutic levels, early battery depletion, inconsistent or inappropriate stimulation and painful or shocking sensations. These issues necessarily prompt identification and correction to prevent serious health risks and ensure the safety and efficacy of the therapy.
In the first quarter of 2024, the company reported a 25% year-over-year increase in U.S. revenues, banking on increased market penetration of Inspire therapy. The recall of the Inspire IV IPG model 3028 might dampen the company’s future sales.
Industry Prospects
Per Verified Market Reports, the global implantable pulse generator market size was valued at $118.57 billion in 2023. It is anticipated to reach $188.76 billion in 2030 at a CAGR of 8.6%.
The market for implantable pulse generators is expanding significantly due to advances in medical technology and the rising incidence of neurological illnesses and chronic pain. In response to patient preferences for less intrusive treatments, smaller and more effective devices with improved battery life and wireless communication are being developed. The growing need for smart features and individualized therapy is also shaping implantable pulse generator developments.
Price Performance
Shares of Inspire Medical have declined 35.4% so far this year compared with the industry's 19.5% decline. The S&P 500 has witnessed a 17.5% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Inspire Medical carries a Zacks Rank #4 (Sell).
Some top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Universal Health Services (UHS - Free Report) and Ecolab Inc. (ECL - Free Report) .
DaVita, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 43.4% compared with the industry’s 15.2% rise in the past year.
Universal Health Services, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.80%. UHS’ earnings surpassed estimates in the trailing four quarters, with an average of 8.12%.
Universal Health Services has gained 21.3% against the industry’s 20.4% decline in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 14.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.3%.
Ecolab’s shares have rallied 31.3% against the industry’s 12.9% decline in the past year.