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Medtronic’s Busy Period for Research & Development

Medtronic’s Busy Period for Research & Development

According to two-year follow-up data from the RESOLUTE US trial, Medtronic's Resolute-Drug-Eluting Stent (DES) holds a powerful and consistent treatment option for a wide variety of patients with coronary artery disease, including those with diabetes mellitus. Are included. Resolute DES was approved by the FDA in February 2012, providing a specific indication for the treatment of coronary artery disease in patients with diabetes mellitus.

The RESOLUTE US trial recruited 1,402 patients at 128 US-based clinical trial sites. Two-year outcomes among 1,359 patients included lower rates of TLF (7.3 percent), clinically operated TLR (4.3 percent), and DET / Probe ST (0.2 percent). 

These results were achieved despite 34 percent of patients with diabetes mellitus, which usually leads to higher incidence rates. In 474 patients with diabetes in the RESOLUTE US, Resolute DES showed lower two-year rates of TLF (8.9 percent) and clinically operated TLR (5.7 percent) and no def / probe ST (0.0 percent).

The rhythmic analysis provided by the RESOLUTE clinical program worldwide, a large randomized controlled trial, and a series of confirmatory single-arm studies involving approximately 250 sites in 32 countries are under consideration. 

In total, the program enrolled 5,130 patients who received a Resolute Des; Approximately one-third of these patients (n = 1,535) had diabetes, a ratio that accrues to the American patient for percutaneous coronary intervention (PCI).

For safety and diabetes-related analyzes, two-year data were included on more than 5,000 patients of the RESOLUTE program receiving the resolution DES. Individual tests, designed for multiple composite endpoints, are often reduced to show true differences for low-frequency, but clinically significant adverse events Skywalkers board bluetooth.

A two-year update for RESOLUTE pooled safety showed very low rates of clinically driven TLR (4.7 percent) and DEF/probe ST (0.9 percent), while 46 percent of patients in the RESOLUTE program were considered complicit. 

Additionally, a two-year update for RESOLUTE rhythmic diabetes, which presents clinical outcomes to diabetic patients with and without diabetes, despite a high-risk disposition of the diabetic patient population with a consistently low incidence rate. Shows up to two years.

In a separate development, two clinical trials related to Electronics' Simplicity Renal Denervation System suggest that treatment provides safe, significant, and sustained blood pressure reduction for up to three years in patients with treatment-resistant hypertension. 

The system has not yet been cleared for the US market but has been available since April 2010 in Europe, Asia, Africa, Australia, and parts of the US. The FDA granted Metronomic approval in August 2011 to improve the US trial of the Simplicity System for the protocol for SIMPLICITY NTH-3, which was treated for hypertension.

Renal desorption therapy is a minimally invasive, catheter-based procedure that modulates the output of nerves that lie within the renal artery wall and outside and inside the kidney. These veins are part of the sympathetic nervous system, which affects the major organs responsible for regulating blood pressure: the brain, heart, kidneys, and blood vessels.

Symptoms HTN-1 is a series of pilot studies involving 153 patients from 19 centers in Australia, Europe, and the US. Subjects in the trial maintained a mean blood pressure reduction of −33 / −19 mm Hg from baseline (P <.001) to 36 months (n = 24) after treatment with the Simplicity system. 

There was a decrease of at least 10 mm Hg in systolic blood pressure in the proportion of patients completing follow-up. In six months 71 percent of the patients were classified as responders, which increased to 100 percent among the patients who completed the three-year follow-up. There was no evidence of renal weakness, no hospitalization due to hypotension, and no procedure-related serious adverse events were noted.

The Symptom HTN-2 trial is an international, multi-center, prospective, randomized, safety, and treatment study of the effectiveness of renal protection in patients with resistant hypertension. In total, 106 patients were randomly allocated in a one-to-one ratio with previous treatment to either renal impairment or maintain alone (control group) at 24 participating centers.

At baseline, randomized treatment and control patients had similar hypertension: receiving an average daily diet of five antihypertensive medications, despite both 178/97 mm Hg and 178/98 mm Hg, respectively.

w-up analysis included data from 47 patients initially treated, who at 12 months follow-up sustained their significant drop in blood pressure (-28 / -10 mm Hg [p <0.001] from baseline) with no significant difference from the previously disclosed six month follow-up (-32 / -12 mm Hg [p = 0.16]). 

In addition, 35 qualified patients in the control group who received renal denervation six months post-randomization also showed a similar drop in blood pressure to the treatment arm at 6 months post-procedure (-24 / -8 mm Hg [p = 0.15] from the 6-month treatment arm). Safety results were sustained with no significant decline in kidney function and no late vascular complications.

kids skywalker boards system consists of a flexible catheter and generator. In an endovascular procedure, similar to an angioplasty, the physician inserts the small, flexible simplicity catheter into the femoral artery in the upper thigh and threads it into the renal artery.

Once the catheter tip is in place within the renal artery, the generator is activated to deliver a controlled, low-power radiofrequency energy routine according to an algorithm that aims to deactivate the surrounding renal nerves. 

This, in turn, reduces the hyper-activation of the sympathetic nervous system, which is an established contributor to chronic hypertension. The procedure does not involve a permanent implant.

In the area of pacemakers, Medtronic has released data from a double-blind, randomized study, ISSUE-3, which found that patients who suffered from fainting due to neuro cardiogenic syncope had fewer fainting occurrences when treated with a Medtronic pacemaker.
Medtronic’s Busy Period for Research & Development
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Medtronic’s Busy Period for Research & Development

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