Market Impact on Global Suppliers of Renal Denervation Systems by Pivotal US Trial: Metronics’ Symplicity Renal Denervation System FAILURE at Efficacy Endpoint
Curator and Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 12/8/2015
New Approaches to Denervation Therapy — TCT 2015
UPDATED on 2/22/2014
Cordis Corporation Receives CE Mark for RENLANE Renal Denervation System to Treat Resistant Hypertension
February 21, 2014 09:59 AM Eastern Standard Time
FREMONT, Calif.–(BUSINESS WIRE)–Cordis Corporation announced today that it has received European CE Mark for its RENLANE™ Renal Denervation System for the treatment of patients with resistant hypertension and has completed the first successful cases in Europe. The RENLANE™ System consists of a unique, helical shaped, irrigated, multi-electrode ablation catheter with a multi-channel radiofrequency (RF) ablation system.
“The design of the catheter also makes handling the device very easy.”
The first successful cases were performed by Hannes Reuter, M.D., at the University of Cologne Hospital in Germany. The treated patients were diagnosed with resistant hypertension and had systolic blood pressures greater than or equal to 160 mm Hg, despite undergoing traditional drug therapy with three or more anti-hypertensive medications. All procedures were performed successfully and patients were discharged after one day.
“The novel technological design of the RENLANE™ Renal Denervation Catheter with its configuration of five electrodes and irrigated technology, allows for shorter procedure duration, sparing of contrasting dye and likely more protection of the endothelium,” said Hannes Reuter, M.D., University of Cologne, Germany. “The design of the catheter also makes handling the device very easy.”
Nearly one billion people worldwide live with hypertension, or high blood pressure, and the World Health Organization estimates that it is the cause of one in every eight deaths, making hypertension the third leading cause of death worldwide.1 Chronic high blood pressure is a serious condition that can lead to increased risk of stroke, kidney disease, heart attack and heart failure. It is estimated that between 15 and 30 percent of treated hypertensive patients are resistant to traditional drug therapy, defined as failure to respond to three or more drugs.2 Uncontrolled hypertension is a major risk factor for mortality so alternative therapies such as renal denervation for treatment-resistant patients have emerged to help address this patient population. Additionally, the economic burden of the condition is significant. The International Society of Hypertension estimates the annual cost of healthcare expenditure directly related to elevated blood pressure to be almost $500 billion.3
“Chronic hypertension poses a significant health risk to patients and also places a huge burden on global health care systems,” said Celine Martin, Worldwide President, Cordis Corporation. “We are pleased to make our RENLANE™ Renal Denervation System available to European clinicians in need of solutions for patients who do not respond to traditional drug therapy. And we are looking forward to gaining more experience with this therapy and making it available to more patients in need of treatment around the world.”4
The RENLANE™ Renal Denervation Catheter features five irrigated electrodes located at the tip of the ablation catheter and is used in conjunction with the RENLANE™ Multi-Channel RF generator for energy delivery. It is indicated for use in adult patients (> 18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
The RENLANE™ Renal Denervation System is another addition to Cordis’ broad and growing portfolio of minimally invasive therapies for patients that suffer from cardiovascular disease worldwide. The company is committed to working with leading clinicians to address the significant and growing burden of cardiovascular disease with innovative endovascular solutions that address the clinical needs of our customers and the patients they treat.
About Renal Denervation
Renal denervation is a minimally invasive, catheter-based treatment for resistant hypertension, or high blood pressure that does not respond to traditional drug therapy (three or more drugs). During the procedure, a thin flexible tube called a catheter is inserted through a small incision in the groin and it is then weaved up to the renal arteries through a blood vessel in the leg. Once the catheter tip is placed inside of a renal artery, radiofrequency (RF) energy is delivered to reduce hyperactivity of the surrounding nerves, which causes the kidneys to produce less of the hormones that are responsible for chronic high blood pressure. Both of the renal arteries are treated during the procedure.
About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson Family of Companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company’s innovation, research and development, Cordis partners with clinicians to treat millions of patients who suffer from cardiovascular disease worldwide. More information about Cordis Corporation can be found at http://www.cordis.com.
1. The World Health Report 2012. World Health Organization; 2012:58
2. Pimenta E, Calhoun DA. Resistant hypertension: incidence, prevalence, and prognosis. Circulation. 2012;125:1594-6.
3. Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure related disease, 2001. Lancet. 2008;371:1513-1518.
4. The RENLANE™ Renal Denervation System is not available for sale or use in the United States.
Read more: Cordis Corporation Receives CE Mark for RENLANE Renal Denervation System to Treat Resistant Hypertension – FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/cordis-corporation-receives-ce-mark-renlane-renal-denervation-system-treat-0#ixzz2u64hQ548
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Subject: | 02.21.14 | J&J’s Cordis scores renal denervation CE mark
UPDATED on 2/7/2014
Renal Denervation Before the Fall. Guest: Deepak Bhatt
January 24, 2014
VIEW VIDEO
http://www.medscape.com/viewarticle/819665?nlid=47583_1984&src=wnl_edit_medn_card&uac=93761AJ&spon=2
UPDATED on 1/23/2014
Covidien bails on renal denervation
Covidien said it’s pulling the plug on its OneShot renal denervation device, citing the slow development of the hypertension market.
Covidien (NYSE:COV) said it plans to wind down its OneShot renal denervation program, largely due to “slower than expected development of the renal denervation market,” meaning the end for a U.S. clinical trial of the high blood pressure device.
“This decision resulted from Covidien’s regular review of strategic programs and growth potential for various aspects of its product portfolio,” according to a press release. “Over the next several weeks, the company will collaborate with physicians and the renal denervation community to ensure existing OneShot patients are informed and the currently enrolling clinical trials are transitioned appropriately.”
The OneShot device already had CE Mark approval in the European Union for treating resistant hypertension in April 2012, when Covidien paid $60 million in cash and put another $170 million on the table in milestones.
SIMILAR ENTRIES
The move means the closure of Covidien’s Rapid II trial, which was projected to enroll 253 patients, comparing treatment with the OneShot device with standard drug treatment in patients with resistant hypertension, according to the release.
SOURCE
http://www.massdevice.com/news/covidien-bails-renal-denervation
UPDATED on 1/21/2014
It’s not that Symple! The Rise (and Fall?) of Renal Denervation by Amy Siegel, http://s2nhealth.com
http://s2nhealth.com/2014/01/17/the-rise-and-fall-of-renal-denervation.html#.Ut7Mmxw8JaE
Clinical Trial Results will impact negatively the following players in the Global Supplier Ecosystem for Renal Denervation Systems:
US Campbell, CA Kona Medical is attempting to address these limitations. The system delivers energy from outside the patient to the renal nerves. Ultimately, the procedure will be a “no puncture,” noninvasive technique, compatible with technologies that will allow for temperature and lesion mapping. A noninvasive procedure will allow titration of the therapy— that is, the application of patient-specific dose fractions while monitoring therapeutic effect in between fractions. The basis of the technology is focused ultrasound, not high intensity (HIFU) as one might see and expect in the treatment of tumors, but low-intensity focused ultrasound (LIFU). The biologic underpinnings of this treatment are described in past literature for treating nerves using ultrasound. Kona noninvasive system. The system is depicted in a custom chair; another version of the system is compatible with a standard fluoroscopy or MRI table. Both ultrasound (through elastography and the evolution of temperature mapping and MRI) allow further imaging and analysis of the treatment area. The dose distribution surrounding the artery is that of an annular ring around the wall of the artery. Kona has shown in animal studies that a heat/vibratory cloud at one plane along the artery is highly effective at long-term inhibition of renal nerves with no visible effect on any portion of the artery at any time point.
US, Ronkonkoma, NY & Germany – Paradise by ReCor Medical 6-F compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a more efficient renal denervation procedure First-in-human (15 patients at 3 months) BP drop, mm Hg -32/-16 at 3 mo. The ultrasound transducer lies within a low-pressure balloon that allows for self-centering of the transducer and gentle contact with the artery wall for uniform circumferential denervation. This means that nerves below the surface of the artery wall are damaged in 360° with a single emission. The balloon also enables cooled fluid to circulate during the energy delivery process, thereby cooling the endothelial wall and protecting it from any excessive heating that could be caused by other energy sources or designs. Preliminary F-I-M clinical data for PARADISE were reported previously at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The updated PARADISE data show that systolic blood pressure was reduced by a statistically significant average of 36 mm Hg in 8 patients at 90-days follow-up. The scientific literature demonstrates that only a 5 mm Hg reduction in BP results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.
US, San Leandro, CA The Mercator Bullfrog by Mercator MedSystems, Inc. is a catheter-guided system designed to inject therapeutic agents directly, nonsystemically, and safely through blood vessel walls into adventitial tissues and has received US Food and Drug Administration 510(k) clearance. The Bullfrog catheter is tipped with a balloon-sheathed microneedle and is guided and inflated in a manner similar to an angioplasty catheter but with far lower expansion pressures (2 atm vs 6–20 atm) in vessels of 3 to 6 mm in diameter. It is compatible with 0.014-inch guidewires and 6-F introducer sheaths. When the desired injection site is reached, the balloon is inflated with saline and radiopaque contrast, securing the system for injection and sliding the microneedle through the vessel wall. Nonclinical studies have shown that the Bullfrog catheter is able to deliver up to 5 mL per injection into the renal artery adventitia with no apparent safety concerns. Guanethidine Ismelin) is delivered to the renal artery adventitia to accomplish sympathetic denervation. Given locally, guanethidine is known to induce an autonomic denervation directly and through an immune-mediated pathway. Mercator’s preclinical experiments have shown that guanethidine, injected at appropriate concentrations into the adventitial space around renal arteries, selectively ablates the nerves in the adventitia around the renal artery after a single, 20-minute procedure
US – Laguna Hills, CA – V2 Radiofrequency Baloon by Vessix Vascular, Inc.Bipolar RF balloon catheter REDUCE-HTN pilot (10 patients)
Renal Denervation Technology of Vessix Vascular, Inc. been acquired by Boston Scientific Corporation (BSX) to pay up to $425 Million
BP drop, mm Hg -30/-11 at 1 mo V 2 catheter, a patented noncompliant balloon catheter with RF electrodes and thermistors mounted on the exterior of the balloon, and the proprietary V 2 bipolar RF generator. Once inserted into the renal artery, a 30-second inflation/treatment per renal artery delivers simultaneous RF therapy with independent temperature control to all electrode pairs. V 2 catheter is available in balloon diameters ranging from 4 to 7 mm, with a balloon length of 25 mm. Larger-diameter balloons have eight electrode pairs, and smaller-diameter balloons have four to six electrode pairs made of solid gold, which are biocompatible and facilitate good electrode contact with the renal arterial wall. In addition, the electrodes are radiopaque, allowing the V 2 catheter to be easily visualized under fluoroscopy. Beginning in the first quarter of 2012, the V 2 renal denervation system will be utilized in the company’s first international, multicenter clinical study: REDUCEHTN.
Israel, Tel Aviv – Tivus by Cardiosonic A6-F transducer-tipped catheter, ultrasound energy (Animal data only) The solution for renal denervation is a high-intensity, nonfocused ultrasonic (US) catheter system named TIVUS (Therapeutic IntraVascular UltraSound) (Figure 3). By applying ultrasonic energy, the TIVUS technology enables remote, localized, controlled, and repeatable thermal modulation of the renal vessel wall tissue, resulting in safe renal nerve ablation. The remote thermal effect is located in the adventitia and perivascular region, with no thermal damage to the endothelium and media, therefore, preventing the development of vessel injury processes. Swine kidney tissue NE concentrations at 30- and 90-day follow-up have demonstrated successful renal denervation as witnessed by a 50% or more decline in tissue NE. Localized tissue thermal modulation/ablation, without damage to the blood vessel wall.
US, MN – SYMPLICITY HTN 2 by Medtronic average office-based BP drops ofBP drop, mm Hg 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline. 14 points in 30 days and 27 points after 1 year. Available in Europe. Medtronic is the furthest ahead in its development process, predicting it will get Symplicity on the American market by 2015. catheter in the renal artery near each kidney to deliver radiofrequency energy to ablate the nerves. A single electrode in contrast to St. Jude’s mutli-electrode approach, is already on the road to FDA review with clinical trials approved last summer in the U.S. Symplicity system has been safely used in nearly 5,000 patients since commercialization
1/9/2014 – Pivotal US trial of Metronics’ Symplicity Renal Denervation System for Refractory Hypertension FAILED its Efficacy Endpoint
US, MN – EnligHTN 1 by St Jude radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves Mean office BP changes at one month in BP drop, mm Hg 28 systolic and -10 diastolic after 1 month (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg. St. Jude Medical’s (St. Paul, MN) announcement in late 2011 of the first patient to be enrolled in their first-in-man ARSENAL trial 15 at the University of Adelaide
Renal Denervation: EnligHTN IV Study Called Off and Potential Novel Indications – Diastolic Heart Failure
Ireland, Dublin – OneShot™ by Covidien acquisition of Maya Medical, Saratoga, CA New Irrigated RF Balloon Catheter secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013. Presumably, a filing with the FDA would follow that. the OneShot renal denervation system, was born out of the company’s extensive expertise in radiofrequency (RF) ablation and percutaneous coronary interventions (PCI), drawing upon the benefits and best practice standards of each distinct yet complementary clinical discipline. The result is a unique product platform that could further accelerate the paradigm shift in the management of resistant hypertension. consistent with Maya’s balloon-based approach is the ability to deliver predictable apposition of the RF electrode to the vessel wall for more controlled targeted delivery of the RF energy. By offering a more reliable single-treatment approach coupled with enhanced ease of use and reduced procedure times, Maya Medical believes its OneShot renal denervation system has the potential to significantly expand clinical adoption
http://bmctoday.net/evtoday/2012/02/article.asp?f=renal-artery-denervation-a-brave-new-frontier
1/21/2014
Covidien said it’s pulling the plug on its OneShot renal denervation device, citing the slow development of the hypertension market.
Covidien (NYSE:COV) said it plans to wind down its OneShot renal denervation program, largely due to “slower than expected development of the renal denervation market,” meaning the end for a U.S. clinical trial of the high blood pressure device.
“This decision resulted from Covidien’s regular review of strategic programs and growth potential for various aspects of its product portfolio,” according to a press release. “Over the next several weeks, the company will collaborate with physicians and the renal denervation community to ensure existing OneShot patients are informed and the currently enrolling clinical trials are transitioned appropriately.”
The OneShot device already had CE Mark approval in the European Union for treating resistant hypertension in April 2012, when Covidien paid $60 million in cash and put another $170 million on the table in milestones.
http://www.massdevice.com/news/covidien-bails-renal-denervation
US, Natick, MA Boston Scientific lags behind in the race to cash in on hypertension-treating devices, incoming CEO Michael Mahoney said at a Monday conference that it has a plan for its RDN renal denervation system. As MassDevice reports, Mahoney said Boston Sci expects to secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013.
Renal Denervation Technology of Vessix Vascular, Inc. been acquired by Boston Scientific Corporation (BSX) to pay up to $425 Million
Heartwire Reported on December 09, 2013
Renal Denervation: EnligHTN IV Study Called Off and Potential Novel Indications – Diastolic Heart Failure
SOURCE
Pivotal US trial of Metronics’ Symplicity Renal Denervation System for Refractory Hypertension FAILED its Efficacy Endpoint
In the Press
Medtronic to weigh future of Symplicity renal denervation system after US trial failure
(Ref: Yahoo!News, The Wall Street Journal, StreetInsider, Medtronic)
Medtronic said Thursday that a pivotal US trial of its Symplicity renal denervation system for treatment-resistant hypertension failed to meet its main efficacy endpoint. The company noted that based on the results of the SYMPLICITY HTN-3 study, it will form an independent panel “to make recommendations about the future of the global hypertension clinical trial programme, as well as provide advice on continued…access to the Symplicity technology in countries with regulatory approvals.”
Depending on the panel review, the company said that it plans to suspend enrollment in the three countries where renal denervation hypertension studies are under way, including, the SYMPLICITY HTN-4 trial in the US, the HTN-Japan study in Japan and the HTN-India trial in India. Chief medical officer Rick Kuntz remarked that “we believe this course of action…will help us thoroughly evaluate these findings and determine the appropriate next steps for renal denervation therapy.”
The Symplicity system received CE mark approval in 2008, with Medtronicannouncing last month that regulators in Europe and Australia cleared the Symplicity Spyral catheter and Symplicity G3 radio frequency generator. The device maker said Thursday that it is evaluating the value of its renal denervation assets and believes “a one-time impairment charge in the future will be likely,” but reiterated its revenue outlook and diluted earnings per share guidance for fiscal 2014.
The SYMPLICITY HTN-3 trial randomised 535 patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg to a treatment or a control group, with all participants continuing to take blood pressure medications. The primary endpoints of the study were the change in office blood pressure from baseline to six months and incidence of major adverse events. Co-principal investigator Deepak L. Bhatt noted that the study “met its primary safety endpoint related to the incidence of major adverse events one month following randomisation and renal artery stenosis to six months.”
Related News
- Medtronic Presents Final Three-Year Data From Symplicity HTN-1 Showing Significant and Sustained Drops in Blood Pressure After Treatment with the Symplicity Renal Denervation System
- Medtronic Randomizes First Patients In Symplicity HTN-4, The First U.S. Renal Denervation Clinical Study For Patients With Moderate Uncontrolled Hypertension
- Medtronic presents positive global registry data of Symplicity renal denervation system
- Medtronic Presents Three-Year Results From SYMPLICITY HTN-2 Showing Significant and Sustained Drops in Blood Pressure After Treatment with the Symplicity(TM) Renal Denervation System
- Medtronic Announces FDA Approval to Enroll First U.S. Renal Denervation Clinical Study for Patients with Moderate Uncontrolled Hypertension
Reference Articles
- Medtronic Announces U.S. Renal Denervation Pivotal Trial Fails to Meet Primary Efficacy Endpoint While Meeting Primary Safety Endpoint – (Medtronic)
- Medtronic hypertension device found ineffective in trial – (Yahoo!News)
- Medtronic Symplicity System Misses Efficacy Goals in Study – (The Wall Street Journal)
- Medtronic (MDT) Reports SYMPLICITY HTN-3 Missed Primary Endpoint – (StreetInsider)
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For the ORIGINAL work on
Renal Sympathetic Denervation: Updates on the State of Medicine
the Readers is called to go to the ORIGINAL SOURCES listed below:
Intravascular Stimulation of Autonomics: A Letter from Dr. Michael Scherlag
Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics
Interaction of Nitric Oxide and Prostacyclin in Vascular Endothelium
Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories
The Molecular Biology of Renal Disorders: Nitric Oxide – Part III
http://pharmaceuticalintelligence.com/2012/11/26/the-molecular-biology-of-renal-disorders/
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