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Medtronic IN.PACT Admiral: First FDA-Approved DCB for ISR
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Medtronic plc (MDT - Free Report) recently announced FDA approval for its IN.PACT (TM) Admiral (TM) drug-coated balloon (DCB) for the treatment of in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). This is the first drug-coated balloon that has gained approval for ISR treatment in the U.S.
The approval was based on ISR data presented by IN.PACT Global Study compared to earlier standard percutaneous balloon angioplasty (PTA) control.
Restenosis is the recurrence of stenosis – narrowing of a blood vessel restricting blood flow. When restenosis occurs in spite of the usage of a stent, the condition is called ISR. The stent is placed in the artery to normalize blood flow but over time plaque can form in and around the stent. This is a crucial condition as it is estimated to occur in up to 40% of all stents placed in the superficial femoral artery (SFA).
The IN.PACT Admiral DCB by Medtronic, is a clinically-proven primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA). The DCB’s primary mode of action is physical dilatation of the vessel lumen by percutaneous balloon angioplasty, and the proven paclitaxel drug is intended to prevent artery contraction by minimizing scar tissue formation.
According to the U.C. Davis Medical Center, there has been a fundamental change in approach toward the treatment of complex PAD patients. To date, physicians have limited treatment options for ISR. Accordingly, the latest FDA approval, while offering ISR patients a more advanced and reliable technology, will also help Medtronic to capture share in this untapped market.
For quite some time now, Medtronic has been striving to grow the market for DCBs. As per the company’s fourth-quarter 2016 report, the cardiac and vascular segment witnessed 80% growth following encouraging data from new therapies. It has also received FDA approval for a change to impact labeling, removing requirement or pre-dilatation and replacing it with simple appropriate vessel of preparation. This makes Medtronic the only company in the U.S. to develop, manufacture and sell both atherectomy and DCBs as a combination therapy for SFA.
As per a report by Transparency Market Research, the global coronary stents market is estimated to expand at a CAGR of 6.6% in the period between 2013 and 2019. The study reveals the global coronary stent market’s worth at $8,292 million by 2019. We feel that this new approval for Medtronic’s DCB would help the latter to expand its market.
Zacks Rank & Key Picks
Medtronic currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are GW Pharmaceuticals plc , NuVasive, Inc. and Quidel Corp. (QDEL - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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Medtronic IN.PACT Admiral: First FDA-Approved DCB for ISR
Medtronic plc (MDT - Free Report) recently announced FDA approval for its IN.PACT (TM) Admiral (TM) drug-coated balloon (DCB) for the treatment of in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). This is the first drug-coated balloon that has gained approval for ISR treatment in the U.S.
The approval was based on ISR data presented by IN.PACT Global Study compared to earlier standard percutaneous balloon angioplasty (PTA) control.
Restenosis is the recurrence of stenosis – narrowing of a blood vessel restricting blood flow. When restenosis occurs in spite of the usage of a stent, the condition is called ISR. The stent is placed in the artery to normalize blood flow but over time plaque can form in and around the stent. This is a crucial condition as it is estimated to occur in up to 40% of all stents placed in the superficial femoral artery (SFA).
MEDTRONIC Price
MEDTRONIC Price | MEDTRONIC Quote
The IN.PACT Admiral DCB by Medtronic, is a clinically-proven primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA). The DCB’s primary mode of action is physical dilatation of the vessel lumen by percutaneous balloon angioplasty, and the proven paclitaxel drug is intended to prevent artery contraction by minimizing scar tissue formation.
According to the U.C. Davis Medical Center, there has been a fundamental change in approach toward the treatment of complex PAD patients. To date, physicians have limited treatment options for ISR. Accordingly, the latest FDA approval, while offering ISR patients a more advanced and reliable technology, will also help Medtronic to capture share in this untapped market.
For quite some time now, Medtronic has been striving to grow the market for DCBs. As per the company’s fourth-quarter 2016 report, the cardiac and vascular segment witnessed 80% growth following encouraging data from new therapies. It has also received FDA approval for a change to impact labeling, removing requirement or pre-dilatation and replacing it with simple appropriate vessel of preparation. This makes Medtronic the only company in the U.S. to develop, manufacture and sell both atherectomy and DCBs as a combination therapy for SFA.
As per a report by Transparency Market Research, the global coronary stents market is estimated to expand at a CAGR of 6.6% in the period between 2013 and 2019. The study reveals the global coronary stent market’s worth at $8,292 million by 2019. We feel that this new approval for Medtronic’s DCB would help the latter to expand its market.
Zacks Rank & Key Picks
Medtronic currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical product sector are GW Pharmaceuticals plc , NuVasive, Inc. and Quidel Corp. (QDEL - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>