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Overactive Bladder has traditionally been treated by both Sacral Neuromodulation (SNM) and Percutaneous Tibial Nerve Stimulation (PTNS) and these therapies have been recognized as safe and effective treatment for OAB. SNM, albeit an effective therapy, requires a complex implantation procedure of a large device and extension leads and there are considerable complications associated with the procedure, which requires full anesthesia, and the treatment. PTNS is less invasive, but is administered only at the physician’s clinic and therefore it is an inconvenient treatment, which limits the accessibility and adoption of therapy. BlueWind Medical’s RENOVA iStim™ is an implantable tibial neuromodulation device. Its unique design allows for a simple 30-minute procedure, done under local anesthesia. Routine use of the RENOVA iStim™ is simple and personalized in the comfort of the patient’s home without the need to frequently visit the clinic.
Patient wearable, worn on the ankle
For the treatment of patients with Overactive Bladder and associated symptoms of urinary urgency and frequency, with or without urge incontinence.
The stimulator is implanted through a small incision and is fixed in place with sutures. There is no need to expose the target nerve, as the device is placed in the vicinity of the neurovascular bundle. The implantation procedure lasts approximately 30 minutes and is performed under local anesthesia.
Daily, 30 minutes self-administered treatment while carrying on normal daily activities.
CE Marked. USA: Investigational device. Limited by U.S. Federal Law to investigational use.
In a pilot clinical study conducted in Europe, BlueWind Medical demonstrated the safety and performance of BlueWind RENOVA iStim™.
Symptoms improvement after 6 months
70.6% of patients had greater than 50% reduction in their symptoms or a return to normal voiding
Mean improvment from baseline
The mean improvement in symptom severity was 35.7 at the 6 months FU.
In the urinary incontinence group, the percentage of dry subjects continuously grew after activation from 7.1% 1 month after activation through 20.7% at the 3 months follow-up to 27.6% at the 6 months follow-up. At the 1 month follow-up there was an immediate significant impact of the therapy on subjects where 50% of subjects reported more than 50% Success Response*.
* Success response was defined as ≥50% improvement in leaks/day
The BlueWind Medical neurostimulator is significantly smaller than conventional devices. Advanced technologies allow the transformation to a minimally invasive procedure.
The neurostimulator provides localized targeted treatment vs. widespread stimulation which may unnecessarily stimulate large areas.
Patient wearable provides wireless power without the need for repeated surgeries to replace a depleted battery.
The BlueWind RENOVA™ has a closed loop mechanism which ensures consistent and dependable stimulation maintaining patient’s convenience in everyday activities.
MR conditional for static magnetic field of 1.5 and 3 Tesla.
No wires are tunneled under the skin thus avoiding lead migration or fracture.
Data protection on the BlueWind website
Welcome to the BlueWind Website. We appreciate your interest in our company.
Protection of the personal data you entrust to us is a priority for us, and we want you to
feel safe and secure when you visit our website or use our online offers.
It is important to us that you are fully informed about the personal data that we collect
when you use our online offers and services, and are familiar with how we use them.
Wherever BlueWind processes personal data, such processing is carried out for the
purposes defined in this data privacy statement.
Processing of personal data
Visiting our website
We record and save your computer’s IP address in order to send the contents of our
website visited by you to your computer (e.g. texts, pictures, and files provided for
downloading, etc.) (cf. Art. 6 (1) lit. b GDPR). We also process these data to identify and
pursue any misuse. Legal basis in this case is Art. 6 (1) lit. f GDPR. In this context, our
legitimate interest in data processing is to ensure the due functioning of our website and
the business transacted via the Website.
We also process personal data that you provide voluntarily, e.g. when you make an
inquiry or online appointment, or when you order information material or newsletters.
Legal basis in this case is Art. 6 (1) lit. b GDPR. The data processed by us in this context
include the data of customers, distributors, suppliers to the extent necessary for the
purposes specified within the scope of this data privacy statement.
In as far as we process your data as described above for the purpose of accepting and
processing your inquiry, appointment, or (newsletter) order, you are contractually
bound to make these data available to us. We are unable to process your request
without the data.
Where you have given your consent to the processing of personal data (cf. Art. 6 (1) lit. a
GDPR), you can withdraw your consent at any time. Withdrawal of consent will not
affect the lawfulness of processing based on consent up to the time of withdrawal of
Transfer to third parties
We may transfer your data to the relevant supplier or distributor where it is processed to
deliver the service and support you requested.
This means that information may also be processed by other entities. However, such
processing is limited to the extent required for the purposes defined in this data privacy
statement or to which the other legal entity acting as a service provider / processor has to
follow the instructions given by the controller.
These service providers / processors are bound by instructions. Given this, they are
subject to our requirements, which include processing of your data exclusively in line
with our instructions and in compliance with the applicable Data Protection Act. In
particular, they are contractually bound to treat your data with strict confidentiality, and
are not permitted to process data for other purposes than the ones agreed.
Data transfer to the data processor is effected on the basis of Art. 28 (1) GDPR.
We will not sell your data to third parties or otherwise share them for commercial purposes.
Beyond the above, we will transfer your personal data to prosecution authorities and, if
applicable, damaged third parties without your explicit consent where this is necessary
for clarifying illegal use of our services or for legal prosecution. However, such a transfer
will only take place if there is concrete evidence of illegal conduct or misuse. Transfer of
your data may also take place where this contributes to enforcing the conditions of use
or other agreements. We are also under legal obligation to provide information to certain
public bodies on request. These comprise prosecution authorities, authorities
prosecuting offences punishable by a fine, and financial authorities.
The transfer of these data is based on our legitimate interest in fighting misuse,
prosecuting criminal acts, and securing, asserting, and enforcing claims unless
our interests are overridden by your rights and interests in the protection of your
personal data, Art. 6 (1) lit. f GDPR.
Intended data transfer to third countries
At present, data transfer to third countries is not planned. Otherwise we will establish the
required legal conditions. In particular, you will be informed of the respective
recipients or categories of recipients of the personal data in line with the legal
BlueWind takes appropriate technical and organizational measures to protect any
personal data you provide to BlueWind from accidental or intentional manipulation,
loss, destruction, or access by unauthorized parties. This also applies to any external
services purchased. We verify the effectiveness of our data protection measures and
continuously improve them in line with technological development.
For a user-friendly website experience and to tailor the operations of our website to your
locally on your computer when you visit a website. When you revisit the website on the
same device, the cookie will indicate, for example, that you are a repeat visitor. Cookies
also allow us to analyze the use of our website. They do not include any personal data
and cannot identify you on third-party websites––including those of analytics providers.
We use the following types of cookies:
Standard periods for deletion of data:
Legislation has defined numerous data storage periods and obligations. At the end of
these periods, the relevant data will be routinely deleted. Data that are not affected by
the above storage periods and obligations are deleted or anonymized as soon as the
purposes defined in this data privacy statement no longer apply. Unless this data
privacy statement includes other deviating provisions for data storage, we will store
any data we collect for as long as they are required for the above purposes for which
they were collected.
Other data use and deletion of data
Any further processing or use of your personal data will generally only be carried out to
the extent permitted on the basis of a legal regulation or where you have consented to
data processing or data use. In the case of further processing for other purposes than
the ones for which the data were originally collected, we will inform you about these
other services and provide you with all other significant information before further
Rights concerning the processing of personal data.
Right of access
On request, you have the right to obtain information from us about the personal data
concerning you and processed by us, to the extent defined in Art. 15 GDPR. You can
send your request either by mail or email to the addresses given below.
Right to rectification
You have the right to require us to rectify any inaccurate personal data concerning
you without undue delay (Art. 16 GDPR). For this purpose, please contact the
address given below.
Right to deletion
Where the legal reasons defined in Art. 17 GDPR apply, you have the right to immediate
deletion (“right to be forgotten”) of personal data concerning you. These legal reasons
include: the personal data are no longer necessary for the purposes for which they were
processed, or you withdraw your consent, and there are no other legal grounds for
processing; the data subject objects to the processing (and there are no overriding
legitimate grounds for processing––does not apply to objections to direct advertising).
To assert your above right, please contact the contact address given below.
Right to restriction of processing
If the criteria defined in Art. 18 GDPR are fulfilled, you have the right to restriction of
processing as established in the above article of the GDPR. According to this article,
restriction of processing may be called for in particular if processing is unlawful and the
data subject opposes deletion of the personal data and requests the restriction of their
use instead, or if the data subject has objected to processing according to Art. 21 (1)
GDPR as long as it is unclear whether our legitimate interest overrides the interest of the
data subject. To assert your above right, please contact the contact address given
Right to data portability
You have the right to data portability as defined in Art. 20 GDPR. This means you
have the right to receive the personal data concerning you, which you have provided to
us, in a structured, commonly used, and machine-readable format, and have the
right to transmit those data to another controller, such as another service provider.
Prerequisite is that processing is based on consent or a contract, and is carried out
using automated means. To assert your above right, please contact the contact
address given below.
Right to object
You have the right to object at any time under Art. 21 GDPR to processing of personal
data concerning you which is based on Art 6 (1) lit. e or f GDPR, on grounds relating to
your particular situation. We will desist from processing your personal data unless we
can demonstrate compelling legitimate grounds for processing which override your
interests, rights, and freedoms, or unless processing is for the establishment, exercise,
or defense of legal claims. To assert your above right, please contact the contact
address given below.
Right to file a complaint with a supervisory authority
If you think that processing of personal data concerning you and carried out by us is
unlawful or impermissible, please contact us.
Please address any questions regarding the processing of your personal data,
requests for information, applications, or complaints directly to our data protection
officer, who will be happy to be of service
If you wish to make use of your right to information on the personal data we process on your behalf, you may contact us in the following contact details
PO Box 4101
4614002 Herzeliya, IL
E-Mail: [email protected]
For the purposes of the European data protection legislation (the GDPR and any successor or equivalent legislation in the UK) our EU and UK representatives are:
EU representative: DataRep, Place de L’Université 16, Louvain-La-Neuve, Waals Brabant, 1348, Belgium
UK representative: DataRep, BPM 335368, 372 Old Street, EC1V 9AU, London, United Kingdom
If you would like to raise a question or request to BlueWind’s representatives, you may do so by:
• Using the online webform at www.datarep.com/data-request, or
• Mailing your inquiry at the address listed above (when mailing, pleas address your inquiry or request to DataRap and clearly refer to BlueWind in your correspondence)
Amendment of this data privacy statement