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Cardiovascular Systems Seeks Device Approval in Japan
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Medical device manufacturer Cardiovascular Systems, Inc. recently announced the submission of its Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown for marketing approval at the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The company expects to commence the marketing of this product in Japan from 2018 and is presently looking for a distribution partner there.
Notably, this device, used to treat severely calcified coronary artery disease for easy stent placement, serves as an enhancement to the company’s existing first generation Diamondback 360 coronary OAS Classic Crown. The earlier version is already available in the U.S., since its approval in 2013.
This second-generation OAS integrates a diamond-coated tip for immediate engagement in tight lesions. Moreover, the increased mass of the sanding crown permits lower rotational speed compared to the first generation OAS. The unique orbital mechanism of action for both the first and second generation OAS enables continuous flow of blood during treatment.
The Orbital technology, supported by a large and growing body of medical evidence, has already been used in over 250,000 cases to date. We believe the enhancement of this product will expand Cardiovascular Systems’ Coronary Artery Disease (CAD) product portfolio and thereby boost its revenues in Japan for now.
CAD is a common and life-threatening condition that currently is the second most common cause of death in Japan. Percutaneous Coronary Intervention (PCI) is a common non-surgical procedure used to pace a stent in CAD patients having plaque in their arteries. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a PCI and absence of advanced treatment may lead to major adverse cardiac events (MACE) or even death.
It is worth noting in this context that as per the company’s recently released data from the COAST clinical study, Cardiovascular System’s next-generation OAS has effectively treated 100 CAD patients, in the U.S. and Japan. Evidently the trial results confirmed a 30-day freedom from MACE rate of 85% and a successful stent delivery rate of 99%. Surely this outcome paved the way for the aforementioned submission.
On receiving the approval, Japan will become the first international market to offer a product of Cardiovascular Systems, marking a significant footstep on the company’s part to capture substantial shares in the overseas.
Key Picks in the Sector
At present, Cardiovascular Systems carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector are NuVasive, Inc. , Hutchison China MediTech Ltd. (HCM - Free Report) and GW Pharmaceuticals plc . While NuVasive and GW Pharmaceuticals sport a Zacks Rank #1 (Strong Buy). Hutchison China MediTech carries a Zacks Rank #2 (Buy).
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Cardiovascular Systems Seeks Device Approval in Japan
Medical device manufacturer Cardiovascular Systems, Inc. recently announced the submission of its Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown for marketing approval at the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The company expects to commence the marketing of this product in Japan from 2018 and is presently looking for a distribution partner there.
Notably, this device, used to treat severely calcified coronary artery disease for easy stent placement, serves as an enhancement to the company’s existing first generation Diamondback 360 coronary OAS Classic Crown. The earlier version is already available in the U.S., since its approval in 2013.
This second-generation OAS integrates a diamond-coated tip for immediate engagement in tight lesions. Moreover, the increased mass of the sanding crown permits lower rotational speed compared to the first generation OAS. The unique orbital mechanism of action for both the first and second generation OAS enables continuous flow of blood during treatment.
The Orbital technology, supported by a large and growing body of medical evidence, has already been used in over 250,000 cases to date. We believe the enhancement of this product will expand Cardiovascular Systems’ Coronary Artery Disease (CAD) product portfolio and thereby boost its revenues in Japan for now.
CAD is a common and life-threatening condition that currently is the second most common cause of death in Japan. Percutaneous Coronary Intervention (PCI) is a common non-surgical procedure used to pace a stent in CAD patients having plaque in their arteries. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a PCI and absence of advanced treatment may lead to major adverse cardiac events (MACE) or even death.
It is worth noting in this context that as per the company’s recently released data from the COAST clinical study, Cardiovascular System’s next-generation OAS has effectively treated 100 CAD patients, in the U.S. and Japan. Evidently the trial results confirmed a 30-day freedom from MACE rate of 85% and a successful stent delivery rate of 99%. Surely this outcome paved the way for the aforementioned submission.
On receiving the approval, Japan will become the first international market to offer a product of Cardiovascular Systems, marking a significant footstep on the company’s part to capture substantial shares in the overseas.
Key Picks in the Sector
At present, Cardiovascular Systems carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector are NuVasive, Inc. , Hutchison China MediTech Ltd. (HCM - Free Report) and GW Pharmaceuticals plc . While NuVasive and GW Pharmaceuticals sport a Zacks Rank #1 (Strong Buy). Hutchison China MediTech carries a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>