Boston Scientific inSocialMediaLinkedIn Announces FDA Approval of Its Thermal Vapor Ablation ProductRezūmNew Indications.RezūmTreatment of Benign Prostatic Hyperplasia (BPH) IndicationsFrom the very beginningProstate volume is 30-80cm³ expanded to nowThe 30-150cm³，Applicable for the treatment of prostate tissue with central zone and/or median lobe hyperplasia.According to statisticsPeople Aged 40 and Above Worldwide in 2022Among the above-mentioned males, the number of patients with benign prostatic hyperplasia (BPH) is 327.1 million, with Asia having the largest number of patients. Currently, there are approximately 75 million patients in China.Patients with benign prostatic hyperplasia, andMore than 2 million new patients are added each year.BPH According toThe volume of benign prostatic hyperplasia can be divided into:- Small Volume: The threshold is 30ml (Grade I hyperplasia), and there are approximately 40 million patients with mild hyperplasia in China falling into this category.
- Smaller Volume: 30-50ml is defined as relatively small (Grade II hyperplasia).
- Large Volume: 50-75ml is defined as an enlarged prostate (Grade III hyperplasia), with approximately 30 million moderate hyperplasia patients in China falling into this category.
- Extra-large volume: Prostates larger than 75ml are defined as extremely large prostates (Grade IV hyperplasia), and in China, approximately 7.5 million patients with severe hyperplasia fall into this category.
For patients with giant volume BPH, clinical treatment mainly involves open prostatectomy. WithRezūmAdaptationSymptom expansion, thesePatients with extremely large volume BPH do not need to worry about complications (such as urinary incontinence, loss of sexual function) caused by prostate removal., etc.).They can chooseRezūmThis minimally invasive treatment not only improves the current condition but also...Lower urinary tract symptoms, and will not bringComplications such as urinary incontinence.RezūmIt is the first product to use thermal steam ablation technology for the treatment of BPH.RezūmComposed of a thermal vapor therapy device and a disposable prostate thermal vapor therapy instrument, the ablation catheter is inserted through the urethra into the targeted prostate area and surgical operations are performed under direct visualization via cystoscopic imaging.The principle is to heat sterile water to approximately 103°C to turn it into steam, then deliver the steam to the prostate tissue via a medical device. This causes the hyperplastic prostate tissue to instantly necrotize under high temperature, gradually shrink, and be absorbed by the body, thereby reducing the prostate volume and improving related symptoms such as difficulty in urination.
Thermal Steam Ablation
Thermal vapor ablation utilizes the endothermic effect of liquid water transforming into water vapor. When water is at approximatelyAt 103°C, during the phase change when converting into steam (liquid phase turning into gas phase), the resulting water vapor carries more than five times the energy of the same mass of water.When steam is delivered toProstateDuring tissue ablation, a large amount of heat is released onto the proliferating cells as the steam condenses back into liquid water. This energy transfer causes the cell membranes to rupture immediately (ablation), ultimately leading to cell death.
Of course, thermal ablation treatments are not limited to just Rezūm. There are also other methods such as radiofrequency ablation, microwave ablation, and laser ablation. However, these thermal ablation methods have a significant drawback: the heat energy is too concentrated. The closer to the ablation needle, the higher the temperature, which can lead to uneven and difficult-to-control heating (or cooling), often causing many adverse events (such as incontinence, loss of sexual function, etc.). Although the incidence rate is lower than that of surgical prostatectomy, some patients still endure the suffering brought by these adverse events.
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Thermal Steam Ablation is very different from traditional thermal ablation techniques. When injected under pressure, the steam rapidly travels through the interstitial spaces between cells (convection) within seconds. The energy is evenly distributed across the entire evaporation area and uniformly ablates as the steam condenses back into water. This allows for better temperature control and helps avoid adverse events.
- Extremely Simplified Operation
The average operation time is only 5 to 8 minutes.Traditional surgery requires preoperative anesthesia preparation and postoperative complex care, butRezūmThe treatment can be performed under local anesthesia only. The entire surgery takes only a few minutes and can generally be done in an outpatient setting, allowing the patient to return home on the same day. This truly achieves the so-called "surgery today, back to work tomorrow." The effects will gradually become apparent 1 to 3 months after the surgery.
- Minimize intraoperative injury
Good preservation of the patient's sexual function
RezūmIt can complete a water vapor injection every 9 seconds, which is not only highly efficient but also ensures thorough treatment while reducing the risk of complications. This is because the high temperature of the water vapor has a certain "thermal convection" effect, similar to turning on an air conditioner in a room, which equalizes the temperature within a specific space, ensuring that all tissue cells in each injection area are completely destroyed. However, the heat transfer area of the water vapor is limited, sparing the surrounding tissues from high-temperature damage, thus preserving the urethral mucosa and the blood vessels and nerves around the prostate, allowing the patient’s sexual function to be retained.- Almost no bleeding during the operation
After the injection of water vapor, the temperature of the surrounding tissue can reach 70°C within 0.01 seconds, leading to cell death, including the blood vessels; meanwhile, as the water vapor condenses within the tissue, it causes rapid collapse of the blood vessels, providing immediate hemostasis. Therefore, the surgery can achieve no bleeding or minimal bleeding.
Rezūm Demonstration
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