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It’s no secret that the Food and Drug Administration and the European Commission take very different approaches to how they allow medical devices onto the market. Their different tacks have produced a profound disconnect in how cardiologists on the two continents use two of the newest technologies in their specialty: bioabsorbable vascular scaffolds for coronary disease and renal denervation for controlling treatment-resistant hypertension.
The European Commission granted a CE mark to the first bioabsorbable vascular stent (BVS), Abbott’s Absorb, in 2011, and Abbott announced the launch of international marketing in September 2012. By last May, an Absorb BVS had been placed in more than 50,000 patients worldwide, according to a company spokesperson.
In contrast, the U.S. total of patients who received a BVS is much lower, and is limited to those randomized to receive a BVS in one of the two ongoing U.S. pivotal trials comparing its performance with a second-generation, drug-eluting metallic stent. One of those trials, with 2,000 total patients, completed enrollment in April 2014, but a second slated to have 3,000 total continues to enroll, so the soonest a BVS might come onto the U.S. market is at least 3 years off.
Not only does Europe have tens of thousands of BVS-treated patients, but several established interventional programs there, such as the Thoraxcenter in Rotterdam (the Netherlands), and others in Italy, Spain, Poland, and the Czech Republic, have adopted the BVS as their default approach for treating patients with percutaneous coronary intervention (PCI). For now, a BVS-first approach does not translate into universal use because only about a fifth of all PCI patients have anatomy suitable for BVS placement. But these BVS-first centers are using them in any PCI patient with anatomy that’s appropriate regardless of the severity of their coronary disease or the complexity of their coronary lesion. This means that BVSs have been placed in growing numbers of European patients with myocardial infarctions, acute coronary syndrome, and bifurcations, as well as in other types of clinically advanced PCI patients.
For renal denervation the numbers are not as disparate, but the prevailing attitudes of many thought leaders are. In Europe, Asia, and a few other parts of the world, interventionalists have used the Symplicity catheter, the first renal denervation device on the world market starting in 2010, in more than 5,500 patients as of this August, according to a spokesperson for Medtronic, the company that sells this device.
The consensus among many European interventional cardiologists and hypertension specialists at the annual EuroPCR meeting was that renal denervation is an effective and valuable option for managing otherwise uncontrolled hypertension, when performed carefully and thoroughly in well-selected patients with true drug-resistant hypertension. They stuck with that opinion despite the report in March that renal denervation failed to produce a significant blood pressure reduction compared with a sham procedure in the pivotal U.S. trial, SYMPLICITY HTN 3 (New Engl. J. Med. 2014;370:1393-1401).
A statement from three leading European cardiologists issued under the auspices of the EuroPCR meeting last May spelled out that despite the negative trial findings, "renal denervation is an option in patients with difficult-to-control hypertension, in whom other treatments have failed."
In the United States, the failed pivotal trial seems to have temporarily put U.S. testing of renal denervation on hold as companies and their consultants scramble to figure out how to avoid the problems that doomed SYMPLICITY HTN 3.
U.S. and European cardiologists show agreement in several other new areas of practice, but for BVS and renal denervation the transatlantic divide is stark.
On Twitter @mitchelzoler
It’s no secret that the Food and Drug Administration and the European Commission take very different approaches to how they allow medical devices onto the market. Their different tacks have produced a profound disconnect in how cardiologists on the two continents use two of the newest technologies in their specialty: bioabsorbable vascular scaffolds for coronary disease and renal denervation for controlling treatment-resistant hypertension.
The European Commission granted a CE mark to the first bioabsorbable vascular stent (BVS), Abbott’s Absorb, in 2011, and Abbott announced the launch of international marketing in September 2012. By last May, an Absorb BVS had been placed in more than 50,000 patients worldwide, according to a company spokesperson.
In contrast, the U.S. total of patients who received a BVS is much lower, and is limited to those randomized to receive a BVS in one of the two ongoing U.S. pivotal trials comparing its performance with a second-generation, drug-eluting metallic stent. One of those trials, with 2,000 total patients, completed enrollment in April 2014, but a second slated to have 3,000 total continues to enroll, so the soonest a BVS might come onto the U.S. market is at least 3 years off.
Not only does Europe have tens of thousands of BVS-treated patients, but several established interventional programs there, such as the Thoraxcenter in Rotterdam (the Netherlands), and others in Italy, Spain, Poland, and the Czech Republic, have adopted the BVS as their default approach for treating patients with percutaneous coronary intervention (PCI). For now, a BVS-first approach does not translate into universal use because only about a fifth of all PCI patients have anatomy suitable for BVS placement. But these BVS-first centers are using them in any PCI patient with anatomy that’s appropriate regardless of the severity of their coronary disease or the complexity of their coronary lesion. This means that BVSs have been placed in growing numbers of European patients with myocardial infarctions, acute coronary syndrome, and bifurcations, as well as in other types of clinically advanced PCI patients.
For renal denervation the numbers are not as disparate, but the prevailing attitudes of many thought leaders are. In Europe, Asia, and a few other parts of the world, interventionalists have used the Symplicity catheter, the first renal denervation device on the world market starting in 2010, in more than 5,500 patients as of this August, according to a spokesperson for Medtronic, the company that sells this device.
The consensus among many European interventional cardiologists and hypertension specialists at the annual EuroPCR meeting was that renal denervation is an effective and valuable option for managing otherwise uncontrolled hypertension, when performed carefully and thoroughly in well-selected patients with true drug-resistant hypertension. They stuck with that opinion despite the report in March that renal denervation failed to produce a significant blood pressure reduction compared with a sham procedure in the pivotal U.S. trial, SYMPLICITY HTN 3 (New Engl. J. Med. 2014;370:1393-1401).
A statement from three leading European cardiologists issued under the auspices of the EuroPCR meeting last May spelled out that despite the negative trial findings, "renal denervation is an option in patients with difficult-to-control hypertension, in whom other treatments have failed."
In the United States, the failed pivotal trial seems to have temporarily put U.S. testing of renal denervation on hold as companies and their consultants scramble to figure out how to avoid the problems that doomed SYMPLICITY HTN 3.
U.S. and European cardiologists show agreement in several other new areas of practice, but for BVS and renal denervation the transatlantic divide is stark.
On Twitter @mitchelzoler
It’s no secret that the Food and Drug Administration and the European Commission take very different approaches to how they allow medical devices onto the market. Their different tacks have produced a profound disconnect in how cardiologists on the two continents use two of the newest technologies in their specialty: bioabsorbable vascular scaffolds for coronary disease and renal denervation for controlling treatment-resistant hypertension.
The European Commission granted a CE mark to the first bioabsorbable vascular stent (BVS), Abbott’s Absorb, in 2011, and Abbott announced the launch of international marketing in September 2012. By last May, an Absorb BVS had been placed in more than 50,000 patients worldwide, according to a company spokesperson.
In contrast, the U.S. total of patients who received a BVS is much lower, and is limited to those randomized to receive a BVS in one of the two ongoing U.S. pivotal trials comparing its performance with a second-generation, drug-eluting metallic stent. One of those trials, with 2,000 total patients, completed enrollment in April 2014, but a second slated to have 3,000 total continues to enroll, so the soonest a BVS might come onto the U.S. market is at least 3 years off.
Not only does Europe have tens of thousands of BVS-treated patients, but several established interventional programs there, such as the Thoraxcenter in Rotterdam (the Netherlands), and others in Italy, Spain, Poland, and the Czech Republic, have adopted the BVS as their default approach for treating patients with percutaneous coronary intervention (PCI). For now, a BVS-first approach does not translate into universal use because only about a fifth of all PCI patients have anatomy suitable for BVS placement. But these BVS-first centers are using them in any PCI patient with anatomy that’s appropriate regardless of the severity of their coronary disease or the complexity of their coronary lesion. This means that BVSs have been placed in growing numbers of European patients with myocardial infarctions, acute coronary syndrome, and bifurcations, as well as in other types of clinically advanced PCI patients.
For renal denervation the numbers are not as disparate, but the prevailing attitudes of many thought leaders are. In Europe, Asia, and a few other parts of the world, interventionalists have used the Symplicity catheter, the first renal denervation device on the world market starting in 2010, in more than 5,500 patients as of this August, according to a spokesperson for Medtronic, the company that sells this device.
The consensus among many European interventional cardiologists and hypertension specialists at the annual EuroPCR meeting was that renal denervation is an effective and valuable option for managing otherwise uncontrolled hypertension, when performed carefully and thoroughly in well-selected patients with true drug-resistant hypertension. They stuck with that opinion despite the report in March that renal denervation failed to produce a significant blood pressure reduction compared with a sham procedure in the pivotal U.S. trial, SYMPLICITY HTN 3 (New Engl. J. Med. 2014;370:1393-1401).
A statement from three leading European cardiologists issued under the auspices of the EuroPCR meeting last May spelled out that despite the negative trial findings, "renal denervation is an option in patients with difficult-to-control hypertension, in whom other treatments have failed."
In the United States, the failed pivotal trial seems to have temporarily put U.S. testing of renal denervation on hold as companies and their consultants scramble to figure out how to avoid the problems that doomed SYMPLICITY HTN 3.
U.S. and European cardiologists show agreement in several other new areas of practice, but for BVS and renal denervation the transatlantic divide is stark.
On Twitter @mitchelzoler
